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Table Of Contents

2.1Medical device safety and risk management
2.3Phases in the life span of a medical device
2.4Participants in ensuring the safety of medical devices
2.5The role of each participant/stakeholder
2.6 Shared responsibility for medical device safety and performance
3.1 Critical elements for regulatory attention
3.2Stages of regulatory control
3.3A common framework for medical device regulations
3.4Regulatory tools and general requirements
3.4.1Product control
3.4.2Vendor establishment control
3.4.4Quality system requirements
4.1Objectives
4.2Scope of the four GHTF study groups
4.3Benefits of the GHTF
4.4Final documents from the GHTF
4.5Global Medical Device Nomenclature (GMDN)
5.1What are standards?
5.2Why do we need standards?
5.3Voluntary and mandatory standards
5.4Standards development process
5.5Conformity assessment with standards
5.6National and international standards systems
5.7Identification of standards
5.8Current trends in the use of standards in medical device regulations
1.Increasing the knowledge of the medical device sector
6.1Increasing knowledge of the medical device sector
6.2Establishing basic regulatory programmes
6.2.1Basic legislation
6.2.2Sharing problem reports
6.3.1Advantages of a national policy
6.3.2Classification of medical devices2
6.3.3Medical device product control
6.3.4Product representation control
6.3.5Vendor establishment control
6.3.6The control of home-use, refurbished, and donated devices
6.3.7The re-use of medical devices that are labelled “for single use”
6.3.8Post-market surveillance
6.4Promoting compliance and cooperation
6.5Setting priorities for regulatory programme development
6.6Cautions in interpreting medical device “export certificates”
Priorities on the international agenda
Relationship between ISO9001:1994 and ISO13485:1996
Aide-mémoire for National Medical Device Administrations
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MD Regulations

MD Regulations

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11/11/2011

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