Risk Management File
Professional, ready-to-use QEHS document designed to support effective implementation, documentation, and ongoing compliance with applicable management system requirements.
- Standard
- ISO 13485
- Document Type
- File
- Format
- DOCX
- Language
- English
- Tags
- File, ISO 13485, Medical Devices
A Risk Management File (RMF) template that contains or references every record produced by risk management for a device or device family, including intended use and safety characteristics, hazard identification, risk estimation and evaluation, risk controls, residual risk and the overall benefit-risk conclusion, in line with ISO 14971 and ISO 13485:2016, Clause 7.1. It comes with a completed worked example.
What's Inside
- Purpose and Structure
- RMF Index
- Intended Use and Safety Characteristics
- Intended Use
- Characteristics Related to Safety
- Hazard Identification and Risk Estimation
- Risk Evaluation
- Risk Control Measures
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clauses 4.2.3, 4.5 and 7.1. It fits with the rest of the QEHS Vault ISO 13485 document set.
Format
Supplied as a fully editable Microsoft Word (.docx) file. Add your organisation’s name, logo and details, then use it straight away. Instant download after purchase.
Key Benefits
- Professional, ready-to-use QEHS document designed to support effective implementation, documentation, and ongoing compliance with applicable management system requirements
Reviews
There are no reviews yet.