�ݺ�ߣshows by User: ulmedical

�ݺ�ߣshows by User: ulmedical / http://www.slideshare.net/images/logo.gif �ݺ�ߣshows by User: ulmedical / Tue, 03 Jun 2014 10:33:44 GMT �ݺ�ߣShare feed for �ݺ�ߣshows by User: ulmedical Strategies for meeting FDA's UDI Rule /slideshow/strategies-for-meeting-fdas-udi-rule/35437092 2014ulfdaudistrategies-140603103344-phpapp01
If you are selling medical devices in the US, your devices are subject to new regulatory requirements under the FDA Unique Device Identification (UDI) rule. UL experts have been actively working with customers with gap assessments, project planning and more to support compliance with these requirements. In this webinar, Ms. Linda Chatwin, RAC will be sharing some of our key learnings. UL offers a full suite of services to support compliance with FDA's UDI Rule. For more information, please contact us and request a sell sheet at Medical.Inquiry@ul.com, visit our UDI webpage or speak directly with one of our experts at 1-877-854-3577 or +91 804 138 4434 http://industries.ul.com/blog/us-fda-unique-device-identification-udi-implementation-deadline-in-place-for-medical-devices ]]>
If you are selling medical devices in the US, your devices are subject to new regulatory requirements under the FDA Unique Device Identification (UDI) rule. UL experts have been actively working with customers with gap assessments, project planning and more to support compliance with these requirements. In this webinar, Ms. Linda Chatwin, RAC will be sharing some of our key learnings. UL offers a full suite of services to support compliance with FDA's UDI Rule. For more information, please contact us and request a sell sheet at Medical.Inquiry@ul.com, visit our UDI webpage or speak directly with one of our experts at 1-877-854-3577 or +91 804 138 4434 http://industries.ul.com/blog/us-fda-unique-device-identification-udi-implementation-deadline-in-place-for-medical-devices ]]> Tue, 03 Jun 2014 10:33:44 GMT /slideshow/strategies-for-meeting-fdas-udi-rule/35437092 ulmedical@slideshare.net(ulmedical) Strategies for meeting FDA's UDI Rule ulmedical If you are selling medical devices in the US, your devices are subject to new regulatory requirements under the FDA Unique Device Identification (UDI) rule. UL experts have been actively working with customers with gap assessments, project planning and more to support compliance with these requirements. In this webinar, Ms. Linda Chatwin, RAC will be sharing some of our key learnings. UL offers a full suite of services to support compliance with FDA's UDI Rule. For more information, please contact us and request a sell sheet at Medical.Inquiry@ul.com, visit our UDI webpage or speak directly with one of our experts at 1-877-854-3577 or +91 804 138 4434 http://industries.ul.com/blog/us-fda-unique-device-identification-udi-implementation-deadline-in-place-for-medical-devices <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/2014ulfdaudistrategies-140603103344-phpapp01-thumbnail.jpg?width=120&height=120&fit=bounds" /> If you are selling medical devices in the US, your devices are subject to new regulatory requirements under the FDA Unique Device Identification (UDI) rule. UL experts have been actively working with customers with gap assessments, project planning and more to support compliance with these requirements. In this webinar, Ms. Linda Chatwin, RAC will be sharing some of our key learnings. UL offers a full suite of services to support compliance with FDA's UDI Rule. For more information, please contact us and request a sell sheet at Medical.Inquiry@ul.com, visit our UDI webpage or speak directly with one of our experts at 1-877-854-3577 or +91 804 138 4434 http://industries.ul.com/blog/us-fda-unique-device-identification-udi-implementation-deadline-in-place-for-medical-devices

Strategies for meeting FDA's UDI Rule from ulmedical

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1 eHealth - Medical Systems Interoperability & Mobile Health /ulmedical/e-health-webinar-md-mfr-focused-10292013-v1 ehealthwebinar-mdmfrfocused10292013v1-131030110924-phpapp01
The Medical Device industry is rapidly adopting technologies that enable communication and connectivity of health products and systems to improve both speed and quality of care as well as patient safety. The users (i.e. hospitals and others) are demanding an approach that will support interoperability among multiple independently sourced medical devices. Industry will require standardization to support such interoperability. Government and regulators, on behalf of the patients and in compliance with their mission to protect public health, as well as users and manufacturers require that such interoperability is safe. This complementary webinar will introduce the eHealth sector and applications, outline the challenges and risks inherent in connecting heterogeneous equipment into medical device systems, and provide insights to how manufacturers can demonstrate compliance with the rapidly changing regulatory landscape for interoperable medical devices. This webinar was presented by UL eHealth experts on October 30, 2013. ]]>
The Medical Device industry is rapidly adopting technologies that enable communication and connectivity of health products and systems to improve both speed and quality of care as well as patient safety. The users (i.e. hospitals and others) are demanding an approach that will support interoperability among multiple independently sourced medical devices. Industry will require standardization to support such interoperability. Government and regulators, on behalf of the patients and in compliance with their mission to protect public health, as well as users and manufacturers require that such interoperability is safe. This complementary webinar will introduce the eHealth sector and applications, outline the challenges and risks inherent in connecting heterogeneous equipment into medical device systems, and provide insights to how manufacturers can demonstrate compliance with the rapidly changing regulatory landscape for interoperable medical devices. This webinar was presented by UL eHealth experts on October 30, 2013. ]]> Wed, 30 Oct 2013 11:09:24 GMT /ulmedical/e-health-webinar-md-mfr-focused-10292013-v1 ulmedical@slideshare.net(ulmedical) eHealth - Medical Systems Interoperability & Mobile Health ulmedical The Medical Device industry is rapidly adopting technologies that enable communication and connectivity of health products and systems to improve both speed and quality of care as well as patient safety. The users (i.e. hospitals and others) are demanding an approach that will support interoperability among multiple independently sourced medical devices. Industry will require standardization to support such interoperability. Government and regulators, on behalf of the patients and in compliance with their mission to protect public health, as well as users and manufacturers require that such interoperability is safe. This complementary webinar will introduce the eHealth sector and applications, outline the challenges and risks inherent in connecting heterogeneous equipment into medical device systems, and provide insights to how manufacturers can demonstrate compliance with the rapidly changing regulatory landscape for interoperable medical devices. This webinar was presented by UL eHealth experts on October 30, 2013. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/ehealthwebinar-mdmfrfocused10292013v1-131030110924-phpapp01-thumbnail.jpg?width=120&height=120&fit=bounds" /> The Medical Device industry is rapidly adopting technologies that enable communication and connectivity of health products and systems to improve both speed and quality of care as well as patient safety. The users (i.e. hospitals and others) are demanding an approach that will support interoperability among multiple independently sourced medical devices. Industry will require standardization to support such interoperability. Government and regulators, on behalf of the patients and in compliance with their mission to protect public health, as well as users and manufacturers require that such interoperability is safe. This complementary webinar will introduce the eHealth sector and applications, outline the challenges and risks inherent in connecting heterogeneous equipment into medical device systems, and provide insights to how manufacturers can demonstrate compliance with the rapidly changing regulatory landscape for interoperable medical devices. This webinar was presented by UL eHealth experts on October 30, 2013.

eHealth - Medical Systems Interoperability & Mobile Health from ulmedical

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1 UL Webinar - Updates to the Regulatory Framework in Korea and their impact to IVD and Medical Device Submissions and Important Deadlines /slideshow/ul-webinar-updates-to-the-regulatory-framework-in-korea-and-their-impact-to-ivd-and-medical-device-submissions-and-important-deadlines/24540700 ul2013072302mfdswebinar-130723101905-phpapp02
fIn this presentation UL technical expert, MinYong Choi, formerly with the Korea FDA provides a comprehensive overview of the Regulatory framework for medical and IVD devices in Korea. The presentation includes useful links, and insight into recent and planned changes to the regulations that may affect submissions for market approval.]]>
fIn this presentation UL technical expert, MinYong Choi, formerly with the Korea FDA provides a comprehensive overview of the Regulatory framework for medical and IVD devices in Korea. The presentation includes useful links, and insight into recent and planned changes to the regulations that may affect submissions for market approval.]]> Tue, 23 Jul 2013 10:19:05 GMT /slideshow/ul-webinar-updates-to-the-regulatory-framework-in-korea-and-their-impact-to-ivd-and-medical-device-submissions-and-important-deadlines/24540700 ulmedical@slideshare.net(ulmedical) UL Webinar - Updates to the Regulatory Framework in Korea and their impact to IVD and Medical Device Submissions and Important Deadlines ulmedical fIn this presentation UL technical expert, MinYong Choi, formerly with the Korea FDA provides a comprehensive overview of the Regulatory framework for medical and IVD devices in Korea. The presentation includes useful links, and insight into recent and planned changes to the regulations that may affect submissions for market approval. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/ul2013072302mfdswebinar-130723101905-phpapp02-thumbnail.jpg?width=120&height=120&fit=bounds" /> fIn this presentation UL technical expert, MinYong Choi, formerly with the Korea FDA provides a comprehensive overview of the Regulatory framework for medical and IVD devices in Korea. The presentation includes useful links, and insight into recent and planned changes to the regulations that may affect submissions for market approval.

UL Webinar - Updates to the Regulatory Framework in Korea and their impact to IVD and Medical Device Submissions and Important Deadlines from ulmedical

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1 “CFDA Registration – Market Access Before Investment” delivered by Tim Lin, Technical Manager for UL’s Medical Regulatory Advisory Services /slideshow/cfda-registration-market-access-before-investment-delivered-by-tim-lin-technical-manager-for-uls-medical-regulatory-advisory-services/23543662 ulwebinar-cfdaregistrationjune262013-130626193140-phpapp01
Due to a large population, increasing middle class and government plans to build tens of thousands of hospitals, there is a lot of demand for high quality medical devices in China. For many foreign medical device manufacturers, the regulatory barriers are still significant obstacles. The medical device regulation in China is less harmonized and generally unique from other major markets. The primary challenges tend to be: actual testing, drafting standards, language barriers and license parking. These additional requirements create a delay in the registration process. Foreign manufacturers need to specifically understand the Chinese medical device regulation in advance, and then are able to determine appropriate strategies aimed at successful China market entry. This is the content for a live webinar, "CFDA Registration, Market Access before Investment...Solving the CFDA Challenge" delivered by UL's Tim Lin. Tim is the Senior Technical Consultant working in the Greater China Region. He majored in public health and medical device engineering, and worked as a reviewer in the Taiwan FDA for high and moderate-risk medical device and clinical trial protocol for over 5 years; and also drafted guidance for industry. He is now responsible for risk management file, usability engineering, software validation and CE MDD technical documentation. ]]>
Due to a large population, increasing middle class and government plans to build tens of thousands of hospitals, there is a lot of demand for high quality medical devices in China. For many foreign medical device manufacturers, the regulatory barriers are still significant obstacles. The medical device regulation in China is less harmonized and generally unique from other major markets. The primary challenges tend to be: actual testing, drafting standards, language barriers and license parking. These additional requirements create a delay in the registration process. Foreign manufacturers need to specifically understand the Chinese medical device regulation in advance, and then are able to determine appropriate strategies aimed at successful China market entry. This is the content for a live webinar, "CFDA Registration, Market Access before Investment...Solving the CFDA Challenge" delivered by UL's Tim Lin. Tim is the Senior Technical Consultant working in the Greater China Region. He majored in public health and medical device engineering, and worked as a reviewer in the Taiwan FDA for high and moderate-risk medical device and clinical trial protocol for over 5 years; and also drafted guidance for industry. He is now responsible for risk management file, usability engineering, software validation and CE MDD technical documentation. ]]> Wed, 26 Jun 2013 19:31:40 GMT /slideshow/cfda-registration-market-access-before-investment-delivered-by-tim-lin-technical-manager-for-uls-medical-regulatory-advisory-services/23543662 ulmedical@slideshare.net(ulmedical) “CFDA Registration – Market Access Before Investment” delivered by Tim Lin, Technical Manager for UL’s Medical Regulatory Advisory Services ulmedical Due to a large population, increasing middle class and government plans to build tens of thousands of hospitals, there is a lot of demand for high quality medical devices in China. For many foreign medical device manufacturers, the regulatory barriers are still significant obstacles. The medical device regulation in China is less harmonized and generally unique from other major markets. The primary challenges tend to be: actual testing, drafting standards, language barriers and license parking. These additional requirements create a delay in the registration process. Foreign manufacturers need to specifically understand the Chinese medical device regulation in advance, and then are able to determine appropriate strategies aimed at successful China market entry. This is the content for a live webinar, "CFDA Registration, Market Access before Investment...Solving the CFDA Challenge" delivered by UL's Tim Lin. Tim is the Senior Technical Consultant working in the Greater China Region. He majored in public health and medical device engineering, and worked as a reviewer in the Taiwan FDA for high and moderate-risk medical device and clinical trial protocol for over 5 years; and also drafted guidance for industry. He is now responsible for risk management file, usability engineering, software validation and CE MDD technical documentation. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/ulwebinar-cfdaregistrationjune262013-130626193140-phpapp01-thumbnail.jpg?width=120&height=120&fit=bounds" /> Due to a large population, increasing middle class and government plans to build tens of thousands of hospitals, there is a lot of demand for high quality medical devices in China. For many foreign medical device manufacturers, the regulatory barriers are still significant obstacles. The medical device regulation in China is less harmonized and generally unique from other major markets. The primary challenges tend to be: actual testing, drafting standards, language barriers and license parking. These additional requirements create a delay in the registration process. Foreign manufacturers need to specifically understand the Chinese medical device regulation in advance, and then are able to determine appropriate strategies aimed at successful China market entry. This is the content for a live webinar, "CFDA Registration, Market Access before Investment...Solving the CFDA Challenge" delivered by UL's Tim Lin. Tim is the Senior Technical Consultant working in the Greater China Region. He majored in public health and medical device engineering, and worked as a reviewer in the Taiwan FDA for high and moderate-risk medical device and clinical trial protocol for over 5 years; and also drafted guidance for industry. He is now responsible for risk management file, usability engineering, software validation and CE MDD technical documentation.

“CFDA Registration – Market Access Before Investment” delivered by Tim Lin, Technical Manager for UL’s Medical Regulatory Advisory Services from ulmedical

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1 UL inmetro non active devices - 2012 /slideshow/ul-inmetro-non-active-devices-2012/15002030 ulinmetronon-activedevices-2012-121102155829-phpapp02
UL is an INMETRO certification body for medical devices. With UL, you can integrate your INMETRO certification testing in UL's ILAC accredited labs.]]>
UL is an INMETRO certification body for medical devices. With UL, you can integrate your INMETRO certification testing in UL's ILAC accredited labs.]]> Fri, 02 Nov 2012 15:58:26 GMT /slideshow/ul-inmetro-non-active-devices-2012/15002030 ulmedical@slideshare.net(ulmedical) UL inmetro non active devices - 2012 ulmedical UL is an INMETRO certification body for medical devices. With UL, you can integrate your INMETRO certification testing in UL's ILAC accredited labs. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/ulinmetronon-activedevices-2012-121102155829-phpapp02-thumbnail.jpg?width=120&height=120&fit=bounds" /> UL is an INMETRO certification body for medical devices. With UL, you can integrate your INMETRO certification testing in UL's ILAC accredited labs.

UL inmetro non active devices - 2012 from ulmedical

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1 Ivd webcast june 2012 for slide share /slideshow/ivd-webcast-june-2012-for-slide-share-14998766/14998766 ivdwebcastjune2012forslideshare-121102105613-phpapp01
UL is a notified body under the IVD directive and UL experts understand the impact of the upcoming regulatory revisions. Visit www.ul.com/medical-cemark for more information on working with UL as your Notified Body.]]>
UL is a notified body under the IVD directive and UL experts understand the impact of the upcoming regulatory revisions. Visit www.ul.com/medical-cemark for more information on working with UL as your Notified Body.]]> Fri, 02 Nov 2012 10:56:12 GMT /slideshow/ivd-webcast-june-2012-for-slide-share-14998766/14998766 ulmedical@slideshare.net(ulmedical) Ivd webcast june 2012 for slide share ulmedical UL is a notified body under the IVD directive and UL experts understand the impact of the upcoming regulatory revisions. Visit www.ul.com/medical-cemark for more information on working with UL as your Notified Body. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/ivdwebcastjune2012forslideshare-121102105613-phpapp01-thumbnail.jpg?width=120&height=120&fit=bounds" /> UL is a notified body under the IVD directive and UL experts understand the impact of the upcoming regulatory revisions. Visit www.ul.com/medical-cemark for more information on working with UL as your Notified Body.

Ivd webcast june 2012 for slide share from ulmedical

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1 61010 national difference for slideshare /slideshow/61010-national-difference-for-slideshare/14998740 61010nationaldifferenceforslideshare-121102105331-phpapp02
IEC / UL 61010 is the internationally harmonized safety standard for Laboratory, Test & Measurement and Process Control equipment. ]]>
IEC / UL 61010 is the internationally harmonized safety standard for Laboratory, Test & Measurement and Process Control equipment. ]]> Fri, 02 Nov 2012 10:53:29 GMT /slideshow/61010-national-difference-for-slideshare/14998740 ulmedical@slideshare.net(ulmedical) 61010 national difference for slideshare ulmedical IEC / UL 61010 is the internationally harmonized safety standard for Laboratory, Test & Measurement and Process Control equipment. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/61010nationaldifferenceforslideshare-121102105331-phpapp02-thumbnail.jpg?width=120&height=120&fit=bounds" /> IEC / UL 61010 is the internationally harmonized safety standard for Laboratory, Test & Measurement and Process Control equipment.

61010 national difference for slideshare from ulmedical

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1 https://public.slidesharecdn.com/v2/images/profile-picture.png https://cdn.slidesharecdn.com/ss_thumbnails/2014ulfdaudistrategies-140603103344-phpapp01-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/strategies-for-meeting-fdas-udi-rule/35437092 Strategies for meeting... https://cdn.slidesharecdn.com/ss_thumbnails/ehealthwebinar-mdmfrfocused10292013v1-131030110924-phpapp01-thumbnail.jpg?width=320&height=320&fit=bounds ulmedical/e-health-webinar-md-mfr-focused-10292013-v1 eHealth - Medical Syst... https://cdn.slidesharecdn.com/ss_thumbnails/ul2013072302mfdswebinar-130723101905-phpapp02-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/ul-webinar-updates-to-the-regulatory-framework-in-korea-and-their-impact-to-ivd-and-medical-device-submissions-and-important-deadlines/24540700 UL Webinar - Updates t...