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
3. Risk Analysis The risk analysis is captured in the Risk Assessment and was conducted according to the Risk Management Plan. The following table provides information regarding the data included in the risk analysis performed as part of the risk assessment.
CriteriaData
Number of Risks15
Risk types identifiedData Security, Calculation Error, Connectivity, User Error
Number of Acceptable Risks8
Number of Unacceptable Risks Prior to Risk Controls7
Number of Unacceptable Risks After Risk Controls1
4. Risk Control Measures Risks were reduced as far as possible (AFAP). If a risk was classified as “unacceptable” based on the Risk Matrix, risk control measures were implemented. The following categories of risk control measures were implemented in priority as listed below:
  1. Inherent safety by design
  2. Protective measures
  3. Information for safety
The table below provides data regarding risk control measures implemented.
CriteriaData
Number of Inherent Safety Controls3
Number of Protective Measures2
Number of Information for Safety Controls2
Total Risk Controls Implemented7
5. Overall Residual Risk Following implementation of risk controls, the overall residual risk is acceptable. One risk (incorrect dosing calculation due to extreme user input values) remains unacceptable but is outweighed by the clinical benefits of improved glucose monitoring and dosing accuracy for the majority of use cases, as demonstrated in the clinical evaluation report. 6. Benefit-Risk Assessment The benefit-risk assessment of the product is described in the clinical evaluation and takes into account the overall residual risk of the product evaluated through the risk assessment process. All unacceptable risks, if any, will be identified and compared against the benefits of the product in the clinical evaluation report to determine the overall benefit-risk ratio. 7. Production and Post-Production Risks There has been established a process for the identification and analyzation of potential risks during production and post-production for the medical device. These processes are captured in the following documents:
  • SOP Integrated Software Development
  • SOP Feedback and Complaints Management
  • SOP Clinical Evaluation
  • SOP Problem Resolution
Risks identified during this processes can serve as inputs to the risk management file and may require review of the risk assessment following incorporation of the new risks.

Q&A