D 64v19 - ISO 14971 Application of risk management to medical devices version 2019 - Set of documents
This set of 39 documents is specifically designed to help you implement medical device risk management according to ISO 14971: 2019. This set is a key resource for mastering medical device risks. The documents are ready to use and editable (Word) to adapt to your specific context and needs. These documents are the annexes to the online training course "Project management" and include, among other things, training materials, 8 cases of disastrous risk management, risk support, the process approach, a risk list, various quality tools, good and bad ISO 14971 practices, multiple-choice tests (MCTs), case studies and real-life stories.
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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
Main Content
- 39 documents specifically designed to help you implement risk management of medical devices according to ISO 14971 version 2019
- these documents are provided as annexes to the online training course "Risk management of medical devices". Examples of included documents:
- training materials
- cases of (disastrous) risk management
- list of risks
- evaluate benefit/risk ratio process
- risk policy
- risk management report
- root causes of MD incidents
- good and bad practices ISO 14971
- quiz requirements ISO 14971
- QMS (Quality Management System) tools
- PRS (Problem, Risk, Safety) tools
- Lean tools
- MCTs (Multiple Choice Tests)
- case studies
- true stories
Advantage
- the documents are ready to use and editable (Word/Excel format) to adapt to the specific needs of each organization
Target audience
- risk/quality managers, engineers, and technical teams wishing to implement risk management of MD according to ISO 14971 version 2019
See the Quality Tools set of documents.
See the Kaizen approach set of documents.
See the COQ approach set of documents.
See the Lean approach set of documents.
See also the free "Oxebridge Totally Free ISO 9001:2015 QMS Documentation Template Kit"
| 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) | 67 | |
| 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 | |
| PQBD64v19A38 | True stories | 8 | |
| PQBD64v19AList | List of documents Manage risks of MD | 1 | |
| Total | 218 | ||
