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Integrated course internal auditors according to ISO 13485: 2016, responsible for vigilance, risk management for medical devices
Curriculum
1 Section
11 Lessons
3 Days
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Curriculum
11
2.0
Final test for obtaining the graduation certificate
2.1
Case studies
2.2
Documents accompanying DM. Declaration of Conformity, ISO, CE Certificates, Technical Specification, Work / use instructions, Installation / use / operation manual, FTS, notices, notifications, analysis bulletins, test reports, etc.
2.3
Labeling and packaging DM – ISO 15223/2016
2.4
Risk management analysis and reporting: reporting, incident analysis, market surveillance
2.5
Identification, traceability and life cycle of DM (UDI system – EUDAMED)
2.6
Technical product file TF, DMR
2.7
DM risk management requirements, DM risk-benefit analysis – ISO 14971/2019
2.8
Terminology. Definitions. DM classification according to Regulation 745 and harmonized standards (ISO 13485/2016, ISO 14971/2019, IAF MD9)
2.9
Responsibilities and responsibilities of the person designated as RESPONSIBLE FOR SURVEILLANCE
2.10
Hazards identification
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DM risk management requirements, DM risk-benefit analysis – ISO 14971/2019
Responsibilities and responsibilities of the person designated as RESPONSIBLE FOR SURVEILLANCE
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