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COURSE Legislation in the field of medical devices
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1 Section
7 Lessons
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Curriculum
7
2.0
Case studies
2.1
Accompanying documents DM: Declaration of Conformity, ISO, CE Certificates, Technical Specification, Operating / Operating Instructions, Installation / Operation / Operation Manual, FTS, Opinions, Notifications, Analysis Bulletins, Test Reports, etc.
2.2
DM identification and traceability
2.3
DM labeling and packaging
2.4
Terminology. Definitions. Classification of medical devices according to the mentioned documents
2.5
Presentation / knowledge of the requirements of republished Law 95/2006 and WHO 566/2020, GD 54/2009, GD798 / 2003 and WHO 1009/2016
2.6
Responsibilities and responsibilities of the person designated as Responsible for compliance with regulations specific to the field of medical devices
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Presentation / knowledge of the requirements of republished Law 95/2006 and WHO 566/2020, GD 54/2009, GD798 / 2003 and WHO 1009/2016
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