ºÝºÝߣshows by User: greenlightguru / http://www.slideshare.net/images/logo.gif ºÝºÝߣshows by User: greenlightguru / Mon, 06 Feb 2023 16:26:52 GMT ºÝºÝߣShare feed for ºÝºÝߣshows by User: greenlightguru The Compliance Concern: Challenges and Roadblocks for Ensuring Compliance in 2023 /slideshow/the-compliance-concern-challenges-and-roadblocks-for-ensuring-compliance-in-2023/255728500 2023medtechindustrybenchmarkreportjan27-230206162652-68d33a53
The medical device industry is doubling down on compliance readiness. This is a significant shift from last year when we saw accelerating product development as the main goal. Ensuring compliance is a requirement for continued success, and most importantly, patient safety. The panelists will discuss the challenges device companies face as they manage compliance throughout the product lifecycle.]]>
The medical device industry is doubling down on compliance readiness. This is a significant shift from last year when we saw accelerating product development as the main goal. Ensuring compliance is a requirement for continued success, and most importantly, patient safety. The panelists will discuss the challenges device companies face as they manage compliance throughout the product lifecycle.]]> Mon, 06 Feb 2023 16:26:52 GMT /slideshow/the-compliance-concern-challenges-and-roadblocks-for-ensuring-compliance-in-2023/255728500 greenlightguru@slideshare.net(greenlightguru) The Compliance Concern: Challenges and Roadblocks for Ensuring Compliance in 2023 greenlightguru The medical device industry is doubling down on compliance readiness. This is a significant shift from last year when we saw accelerating product development as the main goal. Ensuring compliance is a requirement for continued success, and most importantly, patient safety. The panelists will discuss the challenges device companies face as they manage compliance throughout the product lifecycle. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/2023medtechindustrybenchmarkreportjan27-230206162652-68d33a53-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> The medical device industry is doubling down on compliance readiness. This is a significant shift from last year when we saw accelerating product development as the main goal. Ensuring compliance is a requirement for continued success, and most importantly, patient safety. The panelists will discuss the challenges device companies face as they manage compliance throughout the product lifecycle.
The Compliance Concern: Challenges and Roadblocks for Ensuring Compliance in 2023 from Greenlight Guru
]]> 44 0 https://cdn.slidesharecdn.com/ss_thumbnails/2023medtechindustrybenchmarkreportjan27-230206162652-68d33a53-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 How Electronic Data Capture Is Transforming the MedTech Industry /slideshow/how-electronic-data-capture-is-transforming-the-medtech-industry/255728496 2023medtechindustrybenchmarkreportjan26-230206162604-61eed797
Clinical research is crucial to the life science industry. But did you know that medical device companies require a different approach? In this discussion, our panelists will talk about the challenges of clinical operations for MedTech, the benefits of leveraging MedTech-specific Electronic Data Capture (EDC) systems, the pitfalls of using outdated clinical data collection methods, such as paper, and much more!]]>
Clinical research is crucial to the life science industry. But did you know that medical device companies require a different approach? In this discussion, our panelists will talk about the challenges of clinical operations for MedTech, the benefits of leveraging MedTech-specific Electronic Data Capture (EDC) systems, the pitfalls of using outdated clinical data collection methods, such as paper, and much more!]]> Mon, 06 Feb 2023 16:26:04 GMT /slideshow/how-electronic-data-capture-is-transforming-the-medtech-industry/255728496 greenlightguru@slideshare.net(greenlightguru) How Electronic Data Capture Is Transforming the MedTech Industry greenlightguru Clinical research is crucial to the life science industry. But did you know that medical device companies require a different approach? In this discussion, our panelists will talk about the challenges of clinical operations for MedTech, the benefits of leveraging MedTech-specific Electronic Data Capture (EDC) systems, the pitfalls of using outdated clinical data collection methods, such as paper, and much more! <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/2023medtechindustrybenchmarkreportjan26-230206162604-61eed797-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Clinical research is crucial to the life science industry. But did you know that medical device companies require a different approach? In this discussion, our panelists will talk about the challenges of clinical operations for MedTech, the benefits of leveraging MedTech-specific Electronic Data Capture (EDC) systems, the pitfalls of using outdated clinical data collection methods, such as paper, and much more!
How Electronic Data Capture Is Transforming the MedTech Industry from Greenlight Guru
]]> 51 0 https://cdn.slidesharecdn.com/ss_thumbnails/2023medtechindustrybenchmarkreportjan26-230206162604-61eed797-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 The ROI of Shifting Mindset From Compliance to Quality /slideshow/the-roi-of-shifting-mindset-from-compliance-to-quality/255728490 2023medtechindustrybenchmarkreportjan25-230206162518-b753986e
Many MedTech companies focus on compliance without considering the importance of quality. In this session, panelists will dive into the differences between compliance vs. quality, the benefits of shifting mindset towards quality, and tips on how to start embedding quality into your organization.]]>
Many MedTech companies focus on compliance without considering the importance of quality. In this session, panelists will dive into the differences between compliance vs. quality, the benefits of shifting mindset towards quality, and tips on how to start embedding quality into your organization.]]> Mon, 06 Feb 2023 16:25:18 GMT /slideshow/the-roi-of-shifting-mindset-from-compliance-to-quality/255728490 greenlightguru@slideshare.net(greenlightguru) The ROI of Shifting Mindset From Compliance to Quality greenlightguru Many MedTech companies focus on compliance without considering the importance of quality. In this session, panelists will dive into the differences between compliance vs. quality, the benefits of shifting mindset towards quality, and tips on how to start embedding quality into your organization. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/2023medtechindustrybenchmarkreportjan25-230206162518-b753986e-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Many MedTech companies focus on compliance without considering the importance of quality. In this session, panelists will dive into the differences between compliance vs. quality, the benefits of shifting mindset towards quality, and tips on how to start embedding quality into your organization.
The ROI of Shifting Mindset From Compliance to Quality from Greenlight Guru
]]> 26 0 https://cdn.slidesharecdn.com/ss_thumbnails/2023medtechindustrybenchmarkreportjan25-230206162518-b753986e-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Leveraging Modern Software Technologies: MedTech’s Best Kept Secret /slideshow/leveraging-modern-software-technologies-medtechs-best-kept-secret/255728482 2023medtechindustrybenchmarkreportjan24-230206162426-af20d9d5
There are several moving pieces that influence a medical device company’s time-to-market and continued success. An often overlooked (yet critical) one is the tools used to manage the product lifecycle. Are your tools working for you or slowing down your success? In this session, panelists will discuss trends from the 2023 survey results, common challenges with disjointed software solutions, the impact of modernizing, and the power of a modern QMS.]]>
There are several moving pieces that influence a medical device company’s time-to-market and continued success. An often overlooked (yet critical) one is the tools used to manage the product lifecycle. Are your tools working for you or slowing down your success? In this session, panelists will discuss trends from the 2023 survey results, common challenges with disjointed software solutions, the impact of modernizing, and the power of a modern QMS.]]> Mon, 06 Feb 2023 16:24:26 GMT /slideshow/leveraging-modern-software-technologies-medtechs-best-kept-secret/255728482 greenlightguru@slideshare.net(greenlightguru) Leveraging Modern Software Technologies: MedTech’s Best Kept Secret greenlightguru There are several moving pieces that influence a medical device company’s time-to-market and continued success. An often overlooked (yet critical) one is the tools used to manage the product lifecycle. Are your tools working for you or slowing down your success? In this session, panelists will discuss trends from the 2023 survey results, common challenges with disjointed software solutions, the impact of modernizing, and the power of a modern QMS. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/2023medtechindustrybenchmarkreportjan24-230206162426-af20d9d5-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> There are several moving pieces that influence a medical device company’s time-to-market and continued success. An often overlooked (yet critical) one is the tools used to manage the product lifecycle. Are your tools working for you or slowing down your success? In this session, panelists will discuss trends from the 2023 survey results, common challenges with disjointed software solutions, the impact of modernizing, and the power of a modern QMS.
Leveraging Modern Software Technologies: MedTech’s Best Kept Secret from Greenlight Guru
]]> 20 0 https://cdn.slidesharecdn.com/ss_thumbnails/2023medtechindustrybenchmarkreportjan24-230206162426-af20d9d5-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Behind the Stats: Expectations vs. Reality of Bringing a Device to Market /slideshow/behind-the-stats-expectations-vs-reality-of-bringing-a-device-to-market/255728353 2023medtechindustrybenchmarkreportjan231-230206161004-7358e495
Learn about what’s currently impacting the broader medical device industry. Our panelists will kick off the week by going over all the trends, statistics, and themes uncovered from the 2023 MedTech Industry Benchmark Survey. The session will uncover major shifts in industry goals, the use of modern Medtech software tools, major gaps in product lifecycle processes, and more. Discover how you can apply these findings as you make decisions within your organization in 2023 and beyond.]]>
Learn about what’s currently impacting the broader medical device industry. Our panelists will kick off the week by going over all the trends, statistics, and themes uncovered from the 2023 MedTech Industry Benchmark Survey. The session will uncover major shifts in industry goals, the use of modern Medtech software tools, major gaps in product lifecycle processes, and more. Discover how you can apply these findings as you make decisions within your organization in 2023 and beyond.]]> Mon, 06 Feb 2023 16:10:04 GMT /slideshow/behind-the-stats-expectations-vs-reality-of-bringing-a-device-to-market/255728353 greenlightguru@slideshare.net(greenlightguru) Behind the Stats: Expectations vs. Reality of Bringing a Device to Market greenlightguru Learn about what’s currently impacting the broader medical device industry. Our panelists will kick off the week by going over all the trends, statistics, and themes uncovered from the 2023 MedTech Industry Benchmark Survey. The session will uncover major shifts in industry goals, the use of modern Medtech software tools, major gaps in product lifecycle processes, and more. Discover how you can apply these findings as you make decisions within your organization in 2023 and beyond. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/2023medtechindustrybenchmarkreportjan231-230206161004-7358e495-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Learn about what’s currently impacting the broader medical device industry. Our panelists will kick off the week by going over all the trends, statistics, and themes uncovered from the 2023 MedTech Industry Benchmark Survey. The session will uncover major shifts in industry goals, the use of modern Medtech software tools, major gaps in product lifecycle processes, and more. Discover how you can apply these findings as you make decisions within your organization in 2023 and beyond.
Behind the Stats: Expectations vs. Reality of Bringing a Device to Market from Greenlight Guru
]]> 27 0 https://cdn.slidesharecdn.com/ss_thumbnails/2023medtechindustrybenchmarkreportjan231-230206161004-7358e495-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Common Misconceptions on Medical Device Risk & Design Controls /slideshow/common-misconceptions-on-medical-device-risk-design-controls/253989154 robggcommonmisconceptionsppt-221103184246-54c17bd8
Learn about common misconceptions on medical device risk and design controls. This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.]]>
Learn about common misconceptions on medical device risk and design controls. This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.]]> Thu, 03 Nov 2022 18:42:46 GMT /slideshow/common-misconceptions-on-medical-device-risk-design-controls/253989154 greenlightguru@slideshare.net(greenlightguru) Common Misconceptions on Medical Device Risk & Design Controls greenlightguru Learn about common misconceptions on medical device risk and design controls. This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/robggcommonmisconceptionsppt-221103184246-54c17bd8-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Learn about common misconceptions on medical device risk and design controls. This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.
Common Misconceptions on Medical Device Risk & Design Controls from Greenlight Guru
]]> 49 0 https://cdn.slidesharecdn.com/ss_thumbnails/robggcommonmisconceptionsppt-221103184246-54c17bd8-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 QMSR Harmonization: The Future of FDA's Quality Management System Regulation /slideshow/qmsr-harmonization-the-future-of-fdas-quality-management-system-regulation/253989143 fdaqmsharmonization-dr-221103184125-36946e1a
Learn about the future of FDA's Quality Management System regulation. This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.]]>
Learn about the future of FDA's Quality Management System regulation. This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.]]> Thu, 03 Nov 2022 18:41:24 GMT /slideshow/qmsr-harmonization-the-future-of-fdas-quality-management-system-regulation/253989143 greenlightguru@slideshare.net(greenlightguru) QMSR Harmonization: The Future of FDA's Quality Management System Regulation greenlightguru Learn about the future of FDA's Quality Management System regulation. This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/fdaqmsharmonization-dr-221103184125-36946e1a-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Learn about the future of FDA&#39;s Quality Management System regulation. This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.
QMSR Harmonization: The Future of FDA's Quality Management System Regulation from Greenlight Guru
]]> 191 0 https://cdn.slidesharecdn.com/ss_thumbnails/fdaqmsharmonization-dr-221103184125-36946e1a-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 QMS from a Regulatory Perspective /slideshow/qms-from-a-regulatory-perspective/253989126 ggbuildingaqmsfromaregulatoryperspectivecarmenbrown-221103184016-bb7d4dc3
Today we will discuss why a QMS is the backbone of Regulatory through the lens of ISO 13845. The presentation will cover the importance of starting a QMS early and ahead of a regulatory strategy. This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.]]>
Today we will discuss why a QMS is the backbone of Regulatory through the lens of ISO 13845. The presentation will cover the importance of starting a QMS early and ahead of a regulatory strategy. This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.]]> Thu, 03 Nov 2022 18:40:16 GMT /slideshow/qms-from-a-regulatory-perspective/253989126 greenlightguru@slideshare.net(greenlightguru) QMS from a Regulatory Perspective greenlightguru Today we will discuss why a QMS is the backbone of Regulatory through the lens of ISO 13845. The presentation will cover the importance of starting a QMS early and ahead of a regulatory strategy. This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/ggbuildingaqmsfromaregulatoryperspectivecarmenbrown-221103184016-bb7d4dc3-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Today we will discuss why a QMS is the backbone of Regulatory through the lens of ISO 13845. The presentation will cover the importance of starting a QMS early and ahead of a regulatory strategy. This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.
QMS from a Regulatory Perspective from Greenlight Guru
]]> 120 0 https://cdn.slidesharecdn.com/ss_thumbnails/ggbuildingaqmsfromaregulatoryperspectivecarmenbrown-221103184016-bb7d4dc3-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Modernizing your QMS to keep up with the Modern Age of Requirements /slideshow/modernizing-your-qms-to-keep-up-with-the-modern-age-of-requirements/253989102 modernqms2022vs-221103183804-3ffb42f7
Learn about the importance of a modern QMS to keep up with changing requirements in the MedTech industry. This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.]]>
Learn about the importance of a modern QMS to keep up with changing requirements in the MedTech industry. This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.]]> Thu, 03 Nov 2022 18:38:04 GMT /slideshow/modernizing-your-qms-to-keep-up-with-the-modern-age-of-requirements/253989102 greenlightguru@slideshare.net(greenlightguru) Modernizing your QMS to keep up with the Modern Age of Requirements greenlightguru Learn about the importance of a modern QMS to keep up with changing requirements in the MedTech industry. This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/modernqms2022vs-221103183804-3ffb42f7-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Learn about the importance of a modern QMS to keep up with changing requirements in the MedTech industry. This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.
Modernizing your QMS to keep up with the Modern Age of Requirements from Greenlight Guru
]]> 8 0 https://cdn.slidesharecdn.com/ss_thumbnails/modernqms2022vs-221103183804-3ffb42f7-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 eMDR Program and Process /slideshow/emdr-program-and-process/253989093 tuvsudemdralirezahemmati-221103183645-812e2181
In this session we will learn about the Why, the What, the Who, and the How for Medical Device Reporting to FDA through eMDR Submissions. This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.]]>
In this session we will learn about the Why, the What, the Who, and the How for Medical Device Reporting to FDA through eMDR Submissions. This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.]]> Thu, 03 Nov 2022 18:36:45 GMT /slideshow/emdr-program-and-process/253989093 greenlightguru@slideshare.net(greenlightguru) eMDR Program and Process greenlightguru In this session we will learn about the Why, the What, the Who, and the How for Medical Device Reporting to FDA through eMDR Submissions. This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/tuvsudemdralirezahemmati-221103183645-812e2181-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> In this session we will learn about the Why, the What, the Who, and the How for Medical Device Reporting to FDA through eMDR Submissions. This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.
eMDR Program and Process from Greenlight Guru
]]> 24 0 https://cdn.slidesharecdn.com/ss_thumbnails/tuvsudemdralirezahemmati-221103183645-812e2181-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Moving up to the State of the Art in Risk Management /slideshow/moving-up-to-the-state-of-the-art-in-risk-management/253989083 stateoftheartinriskmanagement-221103183541-fb75459f
During this presentation we will explore where Medical Device Risk Management Systems are today. We will look at the quickly upcoming deadlines for implementing the ISO 14971:2019 3rd Edition, and EN ISO 14971:2019/A11:2021 standards. We will also mention the potential next (4th) edition of ISO 14971, and how the industry may influence the next edition. This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.]]>
During this presentation we will explore where Medical Device Risk Management Systems are today. We will look at the quickly upcoming deadlines for implementing the ISO 14971:2019 3rd Edition, and EN ISO 14971:2019/A11:2021 standards. We will also mention the potential next (4th) edition of ISO 14971, and how the industry may influence the next edition. This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.]]> Thu, 03 Nov 2022 18:35:41 GMT /slideshow/moving-up-to-the-state-of-the-art-in-risk-management/253989083 greenlightguru@slideshare.net(greenlightguru) Moving up to the State of the Art in Risk Management greenlightguru During this presentation we will explore where Medical Device Risk Management Systems are today. We will look at the quickly upcoming deadlines for implementing the ISO 14971:2019 3rd Edition, and EN ISO 14971:2019/A11:2021 standards. We will also mention the potential next (4th) edition of ISO 14971, and how the industry may influence the next edition. This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/stateoftheartinriskmanagement-221103183541-fb75459f-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> During this presentation we will explore where Medical Device Risk Management Systems are today. We will look at the quickly upcoming deadlines for implementing the ISO 14971:2019 3rd Edition, and EN ISO 14971:2019/A11:2021 standards. We will also mention the potential next (4th) edition of ISO 14971, and how the industry may influence the next edition. This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.
Moving up to the State of the Art in Risk Management from Greenlight Guru
]]> 86 0 https://cdn.slidesharecdn.com/ss_thumbnails/stateoftheartinriskmanagement-221103183541-fb75459f-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 ISO 13485: What's Next? /slideshow/iso-13485-whats-next/253989062 iso13485-whatsnextggwebinar-221103183401-dcbba064
While ISO 13485 is written in black and white, the alignment between the standard's requirements and expectations is not always clear - especially in regards to SaMD (software as a medical device). This session will discuss aligning ISO 13485 with best practices for SaMD, and how we can expect the shift of the industry to impact the anchor standard of the medical device industry. This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.]]>
While ISO 13485 is written in black and white, the alignment between the standard's requirements and expectations is not always clear - especially in regards to SaMD (software as a medical device). This session will discuss aligning ISO 13485 with best practices for SaMD, and how we can expect the shift of the industry to impact the anchor standard of the medical device industry. This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.]]> Thu, 03 Nov 2022 18:34:01 GMT /slideshow/iso-13485-whats-next/253989062 greenlightguru@slideshare.net(greenlightguru) ISO 13485: What's Next? greenlightguru While ISO 13485 is written in black and white, the alignment between the standard's requirements and expectations is not always clear - especially in regards to SaMD (software as a medical device). This session will discuss aligning ISO 13485 with best practices for SaMD, and how we can expect the shift of the industry to impact the anchor standard of the medical device industry. This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/iso13485-whatsnextggwebinar-221103183401-dcbba064-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> While ISO 13485 is written in black and white, the alignment between the standard&#39;s requirements and expectations is not always clear - especially in regards to SaMD (software as a medical device). This session will discuss aligning ISO 13485 with best practices for SaMD, and how we can expect the shift of the industry to impact the anchor standard of the medical device industry. This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.
ISO 13485: What's Next? from Greenlight Guru
]]> 370 0 https://cdn.slidesharecdn.com/ss_thumbnails/iso13485-whatsnextggwebinar-221103183401-dcbba064-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Computer Software Assurance (CSA): Understanding the FDA’s New Draft Guidance /slideshow/computer-software-assurance-csa-understanding-the-fdas-new-draft-guidance/253989011 20221101greenlighgurucsapresentation-221103182706-aa685a64
Understand the FDA's new draft guidance on Computer Software Assurance (CSA). This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.]]>
Understand the FDA's new draft guidance on Computer Software Assurance (CSA). This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.]]> Thu, 03 Nov 2022 18:27:05 GMT /slideshow/computer-software-assurance-csa-understanding-the-fdas-new-draft-guidance/253989011 greenlightguru@slideshare.net(greenlightguru) Computer Software Assurance (CSA): Understanding the FDA’s New Draft Guidance greenlightguru Understand the FDA's new draft guidance on Computer Software Assurance (CSA). This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/20221101greenlighgurucsapresentation-221103182706-aa685a64-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Understand the FDA&#39;s new draft guidance on Computer Software Assurance (CSA). This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.
Computer Software Assurance (CSA): Understanding the FDA’s New Draft Guidance from Greenlight Guru
]]> 1385 0 https://cdn.slidesharecdn.com/ss_thumbnails/20221101greenlighgurucsapresentation-221103182706-aa685a64-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Making Headway Despite the Turbulence: Regulatory Requirements, Quality, and your QMS /slideshow/making-headway-despite-the-turbulence-regulatory-requirements-quality-and-your-qms/252889750 ggtalk3-makingheadwaydespitetheturbulencefinal-220908184127-880f4e63
The European Union’s In Vitro Diagnostic Medical Devices Regulation, or IVDR, became effective May 26, 2022. In this session, you’ll get a glimpse of what’s changed since implementation day, the latest guidance available, and ways to keep your IVDD to IVDR transition moving forward. This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.]]>
The European Union’s In Vitro Diagnostic Medical Devices Regulation, or IVDR, became effective May 26, 2022. In this session, you’ll get a glimpse of what’s changed since implementation day, the latest guidance available, and ways to keep your IVDD to IVDR transition moving forward. This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.]]> Thu, 08 Sep 2022 18:41:27 GMT /slideshow/making-headway-despite-the-turbulence-regulatory-requirements-quality-and-your-qms/252889750 greenlightguru@slideshare.net(greenlightguru) Making Headway Despite the Turbulence: Regulatory Requirements, Quality, and your QMS greenlightguru The European Union’s In Vitro Diagnostic Medical Devices Regulation, or IVDR, became effective May 26, 2022. In this session, you’ll get a glimpse of what’s changed since implementation day, the latest guidance available, and ways to keep your IVDD to IVDR transition moving forward. This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/ggtalk3-makingheadwaydespitetheturbulencefinal-220908184127-880f4e63-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> The European Union’s In Vitro Diagnostic Medical Devices Regulation, or IVDR, became effective May 26, 2022. In this session, you’ll get a glimpse of what’s changed since implementation day, the latest guidance available, and ways to keep your IVDD to IVDR transition moving forward. This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.
Making Headway Despite the Turbulence: Regulatory Requirements, Quality, and your QMS from Greenlight Guru
]]> 24 0 https://cdn.slidesharecdn.com/ss_thumbnails/ggtalk3-makingheadwaydespitetheturbulencefinal-220908184127-880f4e63-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Reducing Friction Between Companies and Regulatory Bodies /greenlightguru/reducing-friction-between-companies-and-regulatory-bodies reducingfrictionbetweencompaniesandregulatorybodies20220901-220908183731-2556f0d1
We are operating in a complex environment, which is still undergoing changes. A lack of regulatory/quality management resources can be seen on both notified bodies and the industry. To overcome these hurdles, close collaboration and communication between companies and the notified body is necessary. This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.]]>
We are operating in a complex environment, which is still undergoing changes. A lack of regulatory/quality management resources can be seen on both notified bodies and the industry. To overcome these hurdles, close collaboration and communication between companies and the notified body is necessary. This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.]]> Thu, 08 Sep 2022 18:37:31 GMT /greenlightguru/reducing-friction-between-companies-and-regulatory-bodies greenlightguru@slideshare.net(greenlightguru) Reducing Friction Between Companies and Regulatory Bodies greenlightguru We are operating in a complex environment, which is still undergoing changes. A lack of regulatory/quality management resources can be seen on both notified bodies and the industry. To overcome these hurdles, close collaboration and communication between companies and the notified body is necessary. This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/reducingfrictionbetweencompaniesandregulatorybodies20220901-220908183731-2556f0d1-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> We are operating in a complex environment, which is still undergoing changes. A lack of regulatory/quality management resources can be seen on both notified bodies and the industry. To overcome these hurdles, close collaboration and communication between companies and the notified body is necessary. This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.
Reducing Friction Between Companies and Regulatory Bodies from Greenlight Guru
]]> 10 0 https://cdn.slidesharecdn.com/ss_thumbnails/reducingfrictionbetweencompaniesandregulatorybodies20220901-220908183731-2556f0d1-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Latin American Regulations - What you Don't Know /slideshow/latin-american-regulations-what-you-dont-know/252889671 apresentacaolatinamericapanelbrazilv2-220908183454-3b4d36a3
Central and South America are emerging as hot new Medical Device markets. These two subject matter experts in the area break down everything from regulatory advantages and ethical dilemmas. This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.]]>
Central and South America are emerging as hot new Medical Device markets. These two subject matter experts in the area break down everything from regulatory advantages and ethical dilemmas. This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.]]> Thu, 08 Sep 2022 18:34:54 GMT /slideshow/latin-american-regulations-what-you-dont-know/252889671 greenlightguru@slideshare.net(greenlightguru) Latin American Regulations - What you Don't Know greenlightguru Central and South America are emerging as hot new Medical Device markets. These two subject matter experts in the area break down everything from regulatory advantages and ethical dilemmas. This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/apresentacaolatinamericapanelbrazilv2-220908183454-3b4d36a3-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Central and South America are emerging as hot new Medical Device markets. These two subject matter experts in the area break down everything from regulatory advantages and ethical dilemmas. This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.
Latin American Regulations - What you Don't Know from Greenlight Guru
]]> 43 0 https://cdn.slidesharecdn.com/ss_thumbnails/apresentacaolatinamericapanelbrazilv2-220908183454-3b4d36a3-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Insights on the MedTech Regulatory and Clinical Environment in Israel /slideshow/insights-on-the-medtech-regulatory-and-clinical-environment-in-israel/252889653 greenlightguruevent01sept2022-220908183258-f4f60914
Facts about the high-tech industry of Israel The new medical device law in Israel The regulatory landscape - requirements and market access Performing clinical trials in Israel This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.]]>
Facts about the high-tech industry of Israel The new medical device law in Israel The regulatory landscape - requirements and market access Performing clinical trials in Israel This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.]]> Thu, 08 Sep 2022 18:32:58 GMT /slideshow/insights-on-the-medtech-regulatory-and-clinical-environment-in-israel/252889653 greenlightguru@slideshare.net(greenlightguru) Insights on the MedTech Regulatory and Clinical Environment in Israel greenlightguru Facts about the high-tech industry of Israel The new medical device law in Israel The regulatory landscape - requirements and market access Performing clinical trials in Israel This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/greenlightguruevent01sept2022-220908183258-f4f60914-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Facts about the high-tech industry of Israel The new medical device law in Israel The regulatory landscape - requirements and market access Performing clinical trials in Israel This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.
Insights on the MedTech Regulatory and Clinical Environment in Israel from Greenlight Guru
]]> 205 0 https://cdn.slidesharecdn.com/ss_thumbnails/greenlightguruevent01sept2022-220908183258-f4f60914-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 The Global Guide to Human Factors and Usability Engineering Regulations /slideshow/the-global-guide-to-human-factors-and-usability-engineering-regulations/252889624 2022globalguidetohfueshare-220908182908-18054bc8
The regulatory landscape related to human factors and usability engineering has continued to evolve since FDA issued its draft guidance for human factors over ten years ago. In fact, the international standard for usability engineering, IEC 62366-1: 2015 was amended as recently as 2020. The good news is that the pathway to a successful regulatory strategy, in terms of human factors and usability engineering, has never been more clear. The regulators have spoken, by way of guidance and standards documents, all that is left to do is to make sense of it all as it relates to your specific device or product. This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.]]>
The regulatory landscape related to human factors and usability engineering has continued to evolve since FDA issued its draft guidance for human factors over ten years ago. In fact, the international standard for usability engineering, IEC 62366-1: 2015 was amended as recently as 2020. The good news is that the pathway to a successful regulatory strategy, in terms of human factors and usability engineering, has never been more clear. The regulators have spoken, by way of guidance and standards documents, all that is left to do is to make sense of it all as it relates to your specific device or product. This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.]]> Thu, 08 Sep 2022 18:29:08 GMT /slideshow/the-global-guide-to-human-factors-and-usability-engineering-regulations/252889624 greenlightguru@slideshare.net(greenlightguru) The Global Guide to Human Factors and Usability Engineering Regulations greenlightguru The regulatory landscape related to human factors and usability engineering has continued to evolve since FDA issued its draft guidance for human factors over ten years ago. In fact, the international standard for usability engineering, IEC 62366-1: 2015 was amended as recently as 2020. The good news is that the pathway to a successful regulatory strategy, in terms of human factors and usability engineering, has never been more clear. The regulators have spoken, by way of guidance and standards documents, all that is left to do is to make sense of it all as it relates to your specific device or product. This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/2022globalguidetohfueshare-220908182908-18054bc8-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> The regulatory landscape related to human factors and usability engineering has continued to evolve since FDA issued its draft guidance for human factors over ten years ago. In fact, the international standard for usability engineering, IEC 62366-1: 2015 was amended as recently as 2020. The good news is that the pathway to a successful regulatory strategy, in terms of human factors and usability engineering, has never been more clear. The regulators have spoken, by way of guidance and standards documents, all that is left to do is to make sense of it all as it relates to your specific device or product. This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.
The Global Guide to Human Factors and Usability Engineering Regulations from Greenlight Guru
]]> 83 0 https://cdn.slidesharecdn.com/ss_thumbnails/2022globalguidetohfueshare-220908182908-18054bc8-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 MDSAP Certification: Success and Failures /slideshow/mdsap-certification-success-and-failures/252889611 mdsappresentationaug2022-220908182735-45c63f50
Join industry expert, Danny Kroo, key takeaways from the session include: 1. What is MDSAP and when should you consider it? 2. How to prepare for an MDSAP certification audit 3. What are common nonconformities issued by auditing organizations This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.]]>
Join industry expert, Danny Kroo, key takeaways from the session include: 1. What is MDSAP and when should you consider it? 2. How to prepare for an MDSAP certification audit 3. What are common nonconformities issued by auditing organizations This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.]]> Thu, 08 Sep 2022 18:27:35 GMT /slideshow/mdsap-certification-success-and-failures/252889611 greenlightguru@slideshare.net(greenlightguru) MDSAP Certification: Success and Failures greenlightguru Join industry expert, Danny Kroo, key takeaways from the session include: 1. What is MDSAP and when should you consider it? 2. How to prepare for an MDSAP certification audit 3. What are common nonconformities issued by auditing organizations This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/mdsappresentationaug2022-220908182735-45c63f50-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Join industry expert, Danny Kroo, key takeaways from the session include: 1. What is MDSAP and when should you consider it? 2. How to prepare for an MDSAP certification audit 3. What are common nonconformities issued by auditing organizations This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.
MDSAP Certification: Success and Failures from Greenlight Guru
]]> 112 0 https://cdn.slidesharecdn.com/ss_thumbnails/mdsappresentationaug2022-220908182735-45c63f50-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 QMSR Harmonization - The Good the Bad and the Ugly /slideshow/qmsr-harmonization-the-good-the-bad-and-the-ugly/252889566 rcaqmsrharmonization08302022-220908182221-1c8b3ede
Learn about the proposed QMSR rule, intended benefits of MDSAP for the regulatory authorities, benefits for the manufacturer, and similarities between ISO 13485 and FDA Regulations, and more! This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.]]>
Learn about the proposed QMSR rule, intended benefits of MDSAP for the regulatory authorities, benefits for the manufacturer, and similarities between ISO 13485 and FDA Regulations, and more! This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.]]> Thu, 08 Sep 2022 18:22:20 GMT /slideshow/qmsr-harmonization-the-good-the-bad-and-the-ugly/252889566 greenlightguru@slideshare.net(greenlightguru) QMSR Harmonization - The Good the Bad and the Ugly greenlightguru Learn about the proposed QMSR rule, intended benefits of MDSAP for the regulatory authorities, benefits for the manufacturer, and similarities between ISO 13485 and FDA Regulations, and more! This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/rcaqmsrharmonization08302022-220908182221-1c8b3ede-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Learn about the proposed QMSR rule, intended benefits of MDSAP for the regulatory authorities, benefits for the manufacturer, and similarities between ISO 13485 and FDA Regulations, and more! This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.
QMSR Harmonization - The Good the Bad and the Ugly from Greenlight Guru
]]> 96 0 https://cdn.slidesharecdn.com/ss_thumbnails/rcaqmsrharmonization08302022-220908182221-1c8b3ede-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 https://cdn.slidesharecdn.com/profile-photo-greenlightguru-48x48.jpg?cb=1675699794 Greenlight Guru produce beautifully simple quality management software exclusively for medical device companies. greenlight.guru https://cdn.slidesharecdn.com/ss_thumbnails/2023medtechindustrybenchmarkreportjan27-230206162652-68d33a53-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/the-compliance-concern-challenges-and-roadblocks-for-ensuring-compliance-in-2023/255728500 The Compliance Concern... https://cdn.slidesharecdn.com/ss_thumbnails/2023medtechindustrybenchmarkreportjan26-230206162604-61eed797-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/how-electronic-data-capture-is-transforming-the-medtech-industry/255728496 How Electronic Data Ca... https://cdn.slidesharecdn.com/ss_thumbnails/2023medtechindustrybenchmarkreportjan25-230206162518-b753986e-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/the-roi-of-shifting-mindset-from-compliance-to-quality/255728490 The ROI of Shifting Mi...