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D 54v19 - 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

D 54v19 - ISO 14971 Application of risk management to medical devices version 2019 - Set of documents
  • Added the: 20/01/2024
  • Last update: 30/01/2024
  • Number of pages: 205
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Documents provided with the online training T 54v19 Risk management of medical devices


D 54v19 Risk management of medical devices ISO 14971 version 2019
Codification Title Pages
PQBD54v19S Training module Risk management of medical devices, ISO 14971 version 2019 (example of first 35 page, pdf) 62
PQBD54v19A01 8 cases of (disastrous) risk management 5
PQBD54v19A02 Risk level 2
PQBD54v19A03 Process review 2
PQBD54v19A04 Address MD risks process 2
PQBD54v19A05 Monitor post-market process 2
PQBD54v19A06 Glossary 13
PQBD54v19A07 Evaluate benefit-risk ratio 2
PQBD54v19A08 Process approach 3
PQBD54v19A09 Risk management, procedure 8
PQBD54v19A10 Risk support, Excel 10
PQBD54v19A11 List of risks 8
PQBD54v19A12 Risk policy 1
PQBD54v19A13 Address MD risks process review 6
PQBD54v19A14 Decisions and actions 1
PQBD54v19A15 Risk manager job description 2
PQBD54v19A16 Risk management plan 2
PQBD54v19A17 Risk management file 1
PQBD54v19A18 Risk analysis activities 2
PQBD54v19A19 Risk evaluation activities 1
PQBD54v19A20 PRS (problem, risk, safety) tools 20
PQBD54v19A21 Control measures 1
PQBD54v19A22 Benefit-risk ratio 1
PQBD54v19A23 Control measures review 1
PQBD54v19A24 Completeness control review 1
PQBD54v19A25 Accompanying documentation 1
PQBD54v19A26 Risk management report 1
PQBD54v19A27 Post-market monitoring plan, PMMP 2
PQBD54v19A28 Post-market monitoring report, PMMR 2
PQBD54v19A29 List of collected information 1
PQBD54v19A30 Root causes of MD incidents 3
PQBD54v19A31 Collected information review 1
PQBD54v19A32 Periodic safety update report 2
PQBD54v19A33 Good practices ISO 14971 3
PQBD54v19A34 Bad practices ISO 14971 3
PQBD54v19A35 Quiz requirements ISO 14971 8
PQBD54v19A36 MCT (multiple choice test) 10
PQBD54v19A37 Case studies 8
PQBD54v19AList List of documents Manage risks of MD 1
Total 205