1. Define the Intended Use
Preparing an ISO 14971 Risk Management File is the most critical regulatory task for any medical device manufacturer. The file proves to Notified Bodies and the FDA that your device is safe.
2. Identify Hazards
Start by clearly defining the intended use and foreseeable misuse. If you do not constrain the scope of your device, you will be forced to analyze hazards that are practically impossible.
3. Estimate Risks
Next, systematic hazard identification must be performed. Do not rely solely on brainstorming. Use structured prompts based on energy hazards, biological hazards, and use-error scenarios.
4. Implement Controls
For every identified hazardous situation, assign a Probability (P1 x P2) and Severity based on your predefined Risk Management Plan. Once initial risks are scored, implement Risk Controls starting with inherent safety by design, followed by protective measures, and lastly, information for safety.
5. Evaluate Residual Risk
Finally, perform a residual risk evaluation to prove that the medical benefits of the device outweigh the remaining risks.