1) Completing an AiS Challenge project is time consuming and intellectually challenging, so working in teams allows people to use their combined skills, sustain enthusiasm, and support one another to complete the project.
2) Teams work best when members are committed to common objectives, have defined roles and responsibilities, and effective communication, decision-making, and work procedures.
3) Successful teams go through forming, storming, norming, and performing stages where they establish roles and goals, work through conflicts, develop norms and understanding, and become high-performing.
The document discusses achieving success through the review process. It has two main aims: to provide an understanding of the review process and to introduce the SMART approach to objective setting. The review process benefits both individuals and the university by clarifying expectations, improving communication, and celebrating successes. It also discusses different levels of objectives, the annual review cycle, roles and responsibilities, examples of SMART objectives, receiving feedback, and types of development.
The document contains a collection of short quotes and sayings about topics like confidence, success, wisdom, relationships, positivity, and living life to the fullest. Some of the key messages expressed are: gain confidence through practice; think positively and creatively solve challenges; be honest, diligent, and work continuously toward your goals; and make the most of each day as a gift.
China Compulsory Certification Requirement And Procedures Of Medical DeviceJacobe2008
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China has established a China Compulsory Certification (CCC) system for medical devices that is similar to international fifth party certification models. The CCC system requires type testing, initial factory inspections, and follow up inspections. It covers 7 categories of medical devices including medical x-ray equipment, hemodialysis equipment, artificial heart-lung machines, implantable cardiac pacemakers, electrocardiographs. Standards are based on transformed international IEC standards and national standards. The certification process involves application, testing, factory inspection, evaluation, and issuing of certificates. Follow up inspections ensure continued compliance.
The document discusses succession planning for key leadership positions. It defines succession planning as identifying and developing internal talent for senior roles. An effective succession plan involves setting goals, identifying successors, developing successors through training and mentoring, and communicating the transition when it occurs. The plan should be led by current leadership and overseen by the board of directors to ensure continuity and strong governance.
China Compulsory Certification Requirement And Procedures Of Medical DeviceJacobe2008
?
China has a compulsory certification (CCC) requirement for medical devices that went into effect in May 2002. There are 7 categories of devices that require CCC, including medical x-ray equipment, hemodialysis equipment, artificial heart-lung machines, implantable cardiac pacemakers, and electrocardiographs. The CCC process involves type testing, initial factory inspections, and follow-up inspections. Standards are based on translated international IEC standards and certification follows a typical international model of type testing plus initial and follow-up factory audits. Information about CCC, standards, and the certification process is publicly available on government websites.
1) Completing an AiS Challenge project is time consuming and intellectually challenging, so working in teams allows people to use their combined skills, sustain enthusiasm, and support one another to complete the project.
2) Teams work best when members are committed to common objectives, have defined roles and responsibilities, and effective communication, decision-making, and work procedures.
3) Successful teams go through forming, storming, norming, and performing stages where they establish roles and goals, work through conflicts, develop norms and understanding, and become high-performing.
The document discusses achieving success through the review process. It has two main aims: to provide an understanding of the review process and to introduce the SMART approach to objective setting. The review process benefits both individuals and the university by clarifying expectations, improving communication, and celebrating successes. It also discusses different levels of objectives, the annual review cycle, roles and responsibilities, examples of SMART objectives, receiving feedback, and types of development.
The document contains a collection of short quotes and sayings about topics like confidence, success, wisdom, relationships, positivity, and living life to the fullest. Some of the key messages expressed are: gain confidence through practice; think positively and creatively solve challenges; be honest, diligent, and work continuously toward your goals; and make the most of each day as a gift.
China Compulsory Certification Requirement And Procedures Of Medical DeviceJacobe2008
?
China has established a China Compulsory Certification (CCC) system for medical devices that is similar to international fifth party certification models. The CCC system requires type testing, initial factory inspections, and follow up inspections. It covers 7 categories of medical devices including medical x-ray equipment, hemodialysis equipment, artificial heart-lung machines, implantable cardiac pacemakers, electrocardiographs. Standards are based on transformed international IEC standards and national standards. The certification process involves application, testing, factory inspection, evaluation, and issuing of certificates. Follow up inspections ensure continued compliance.
The document discusses succession planning for key leadership positions. It defines succession planning as identifying and developing internal talent for senior roles. An effective succession plan involves setting goals, identifying successors, developing successors through training and mentoring, and communicating the transition when it occurs. The plan should be led by current leadership and overseen by the board of directors to ensure continuity and strong governance.
China Compulsory Certification Requirement And Procedures Of Medical DeviceJacobe2008
?
China has a compulsory certification (CCC) requirement for medical devices that went into effect in May 2002. There are 7 categories of devices that require CCC, including medical x-ray equipment, hemodialysis equipment, artificial heart-lung machines, implantable cardiac pacemakers, and electrocardiographs. The CCC process involves type testing, initial factory inspections, and follow-up inspections. Standards are based on translated international IEC standards and certification follows a typical international model of type testing plus initial and follow-up factory audits. Information about CCC, standards, and the certification process is publicly available on government websites.
Federal Regulatory Issues Us Food And Drug Administration Medical Device Amen...Jacobe2008
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Authors:
Harvard-MIT Division of Health Sciences and Technology HST.535: Principles and Practice of Tissue Engineering Instructors: Myron Spector
Massachusetts Institute of Technology
Harvard Medical School Brigham and Women's Hospital VA Boston Healthcare
This document discusses risk management for medical devices. It defines key risk management terms and concepts. The risk management process involves risk assessment, analysis, evaluation, and control. Risk assessment tools include risk matrices, preliminary hazard analysis, fault tree analysis, failure mode and effects analysis, and hazard and operability analysis. Medical device risk management aims to ensure patient, user, and handler safety, as well as manage business and regulatory risks.
This document discusses medical device administration in China. It outlines the competent authorities that regulate medical devices, including the SFDA and Center for Medical Device Evaluation. It also describes the administration activities like registration, production, sales, and post-marketing surveillance. The document then summarizes the laws and regulations regarding medical devices and classifies medical devices into three categories based on risk. It provides details on administration of production, sales, and registration of medical devices in China.
Medical Device Regulations Global Overview And Guiding PrinciplesJacobe2008
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WHO Library Cataloguing-in-Publication Data
World Health Organization.
Medical device regulations : global overview and guiding principles.
1.Equipment and supplies – legislation 2.Equipment and supplies –
standards 3.Policy making 4.Risk management 5.Quality control I.Title.
ISBN 92 4 154618 2 (NLM Classification: WA 26)
This document provides an overview of Japan's healthcare system and medical device market. It summarizes that Japan has universal healthcare coverage for its 127 million citizens, with total healthcare expenditures of $278 billion in 2000. The medical device market in Japan was worth $18 billion in 2000, with the United States having a large trade surplus of $4 billion in medical device exports to Japan. The regulatory system for medical devices is administered by the Ministry of Health and requires government approval and licensing for devices to be sold in Japan.
Statistical Issues In Medical Device TrialsJacobe2008
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Authors:
George Koustenis,
FDA-CDRH
David Breiter,
Boston Scientific
Roseann White,
Abbott Vascular
George Woodworth, Univ. of Iowa
FDA/INDUSTRY STATISTICS WORKSHOP: Washington, D.C. Sept. 29, 2006
This document provides an overview of safety, WEEE-RoHS, and EMC compliance requirements for electronic products being sold in various markets. It discusses regulations in the US, Canada, Europe and other regions regarding electrical safety, hazardous materials restrictions, and electromagnetic compatibility. Evaluation methods are outlined for assessing products for safety hazards, electromagnetic emissions and immunity to interference. The basics of EMC design are also mentioned.