Verification and Validation Stage Checklists
Risk Management Report
Summarize risk management activities demonstrating successful hazard control and regulatory compliance achievement.
Summary
The Risk Management Report summarizes all risk management activities conducted during your medical device development, demonstrating that your Risk Management Plan was executed successfully and that all identified risks have been appropriately controlled or mitigated.Why is Risk Management Report important?
The Risk Management Report serves as the final checkpoint in your risk management process, providing regulatory authorities with evidence that you have systematically identified, analyzed, and controlled all foreseeable risks associated with your medical device. This document is crucial because it demonstrates that your device’s benefits outweigh its residual risks and that you have implemented appropriate risk controls to ensure patient safety. Without a comprehensive Risk Management Report, you cannot demonstrate regulatory compliance or justify that your device is safe for market release.Regulatory Context
Under 21 CFR Part 820 (Quality System Regulation) and FDA Guidance on Risk Management:
- Risk management activities must be documented throughout the device lifecycle
- Risk analysis must be conducted according to recognized standards (ISO 14971)
- Benefit-risk assessment must demonstrate that benefits outweigh residual risks
- Risk management file must be maintained and updated throughout device lifecycle
Special attention required for:
- Software medical devices requiring additional cybersecurity risk considerations
- Combination products requiring coordination between device and drug risk assessments
- Class III devices requiring more extensive risk documentation
- Post-market risk management updates for 510(k) modifications
Guide
Your Risk Management Report must demonstrate that you have successfully executed your Risk Management Plan and that all identified risks are appropriately controlled. The report should provide a comprehensive overview of your risk management activities and their outcomes.Risk Analysis Summary
Document the scope and results of your risk analysis activities. Your risk-analysis-results table should automatically populate with data from your Risk Assessment, showing the total number of risks identified, types of risks found, and how many were initially acceptable versus unacceptable. This provides regulators with a clear picture of the comprehensiveness of your risk analysis.Risk Control Implementation
Detail the risk control measures you implemented for any unacceptable risks. Your risk-controls-results table should categorize your risk controls according to the three-tier hierarchy: inherent safety by design (most preferred), protective measures (second choice), and information for safety (least preferred). Document how many controls you implemented in each category and their effectiveness.Overall Residual Risk Assessment
Provide a clear statement about your device’s overall-residual-risk after all risk controls have been implemented. If any risks remain unacceptable after risk controls, they must be explicitly identified and justified through benefit-risk analysis. Most devices should achieve acceptable overall residual risk through proper risk control implementation.Benefit-Risk Integration
Reference how your risk management outcomes integrate with your clinical evaluation. The clinical evaluation should demonstrate that your device’s clinical benefits outweigh any residual risks, particularly for any risks that remain unacceptable after risk controls.Production and Post-Production Risk Management
Establish clear processes for ongoing risk management throughout your device lifecycle. Reference your relevant SOPs that address how new risks identified during production or post-market surveillance will be incorporated into your risk management file and trigger updates to your risk assessment.Example
Scenario: You develop a mobile health app that monitors blood glucose levels and provides dosing recommendations. During risk analysis, you identify 15 total risks including data security breaches, incorrect dosing calculations, and device connectivity failures. Initially, 8 risks are acceptable and 7 are unacceptable. You implement risk controls including data encryption (inherent safety), user authentication (protective measures), and warning messages (information for safety). After controls, only 1 risk remains unacceptable but is justified through clinical benefit analysis.Risk Management Report
ID: RMR-001 1. Scope The Risk Management Report contains the output and summary of risk management activities for the risk management file. The procedures used for the risk assessment and risk management file in general are captured in the Risk Management Plan and the risk management report is a review that the risk management plan has been executed successfully. Additional information related to the implementation of risk controls and processes related to product development and risk procedures are found in the SOP Integrated Software Development. 2. Relevant Documents- SOP Integrated Software Development
- Risk Management Plan
- Risk Assessment
- Software Requirements List
- Software System Test Plan
- User Needs List
| Criteria | Data |
|---|---|
| Number of Risks | 15 |
| Risk types identified | Data Security, Calculation Error, Connectivity, User Error |
| Number of Acceptable Risks | 8 |
| Number of Unacceptable Risks Prior to Risk Controls | 7 |
| Number of Unacceptable Risks After Risk Controls | 1 |
- Inherent safety by design
- Protective measures
- Information for safety
| Criteria | Data |
|---|---|
| Number of Inherent Safety Controls | 3 |
| Number of Protective Measures | 2 |
| Number of Information for Safety Controls | 2 |
| Total Risk Controls Implemented | 7 |
- SOP Integrated Software Development
- SOP Feedback and Complaints Management
- SOP Clinical Evaluation
- SOP Problem Resolution
Q&A
How can I improve my risk assessment?
How can I improve my risk assessment?
Add more serious risks, particularly around psychological stress, and consider adding “personal harm” as a risk category. Make risk descriptions specific and create test scenarios for each risk to ensure comprehensive coverage.
What should I do if a new risk is identified during vigilance database review?
What should I do if a new risk is identified during vigilance database review?
If a new risk is identified during the vigilance database review, it should be added to the risk assessment to ensure all foreseeable risks are accounted for. Update your Risk Management Report accordingly.
How deep should my risk assessment documentation be?
How deep should my risk assessment documentation be?
Cover all obvious foreseeable risks comprehensively. If there are things that are very unlikely to happen or are not thought of, that’s acceptable. Auditors look for a robust list of foreseeable risks. If something is missed, a minor update can be done later.
What is the recommendation for categorizing software risk components?
What is the recommendation for categorizing software risk components?
It is recommended to categorize at least one component as medium risk to demonstrate risk assessment, even if the software is generally low risk. This shows you have properly considered the risk spectrum.
How should I handle risks that remain unacceptable after risk controls?
How should I handle risks that remain unacceptable after risk controls?
Any risks that remain unacceptable after implementing risk controls must be explicitly documented in the Overall Residual Risk section and justified through benefit-risk analysis in your clinical evaluation. The clinical benefits must clearly outweigh these residual risks.