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D 64v19 - ISO 14971 Application of risk management to medical devices version 2019 - Set of documents

E-Learning (online courses) support - Risk management of medical devices according to ISO 14971 version 2019 - Application - set of 38 documents

 
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D 64v19 - ISO 14971 Application of risk management to medical devices version 2019 - Set of documents
  • Added the: 20/01/2024
  • Last update: 16/10/2024
  • Number of pages: 205
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Description

Documents provided with the online training T 64v19 Risk management of medical devices

 

D 64v19 Risk management of medical devices ISO 14971 version 2019
Codification Title Pages
PQBD64v19S Training module Risk management of medical devices, ISO 14971 version 2019 (example of first 35 page, pdf) 62
PQBD64v19A01 8 cases of (disastrous) risk management 5
PQBD64v19A02 Risk level 2
PQBD64v19A03 Process review 2
PQBD64v19A04 Address MD risks process 2
PQBD64v19A05 Monitor post-market process 2
PQBD64v19A06 Glossary 13
PQBD64v19A07 Evaluate benefit-risk ratio 2
PQBD64v19A08 Process approach 3
PQBD64v19A09 Risk management, procedure 8
PQBD64v19A10 Risk support, Excel 10
PQBD64v19A11 List of risks 8
PQBD64v19A12 Risk policy 1
PQBD64v19A13 Address MD risks process review 6
PQBD64v19A14 Decisions and actions 1
PQBD64v19A15 Risk manager job description 2
PQBD64v19A16 Risk management plan 2
PQBD64v19A17 Risk management file 1
PQBD64v19A18 Risk analysis activities 2
PQBD64v19A19 Risk evaluation activities 1
PQBD64v19A20 PRS (problem, risk, safety) tools 20
PQBD64v19A21 Control measures 1
PQBD64v19A22 Benefit-risk ratio 1
PQBD64v19A23 Control measures review 1
PQBD64v19A24 Completeness control review 1
PQBD64v19A25 Accompanying documentation 1
PQBD64v19A26 Risk management report 1
PQBD64v19A27 Post-market monitoring plan, PMMP 2
PQBD64v19A28 Post-market monitoring report, PMMR 2
PQBD64v19A29 List of collected information 1
PQBD64v19A30 Root causes of MD incidents 3
PQBD64v19A31 Collected information review 1
PQBD64v19A32 Periodic safety update report 2
PQBD64v19A33 Good practices ISO 14971 3
PQBD64v19A34 Bad practices ISO 14971 3
PQBD64v19A35 Quiz requirements ISO 14971 8
PQBD64v19A36 MCT (multiple choice test) 10
PQBD64v19A37 Case studies 8
PQBD64v19AList List of documents Manage risks of MD 1
Total 205