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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See the online training T 64v19 Risk management of MD version 2019 |
You have an unlimited access for one year to the whole set of documents. This includes access to all the modifications (improvements) which could be made during that period.
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 | ||
