Risk Management Plan Template
ISO 14971 compliant risk management plan template for medical devices
Risk Management Plan Template
Document Information
- Document Title: Risk Management Plan for [Device Name]
- Document Number: [Document Number]
- Version: [Version Number]
- Date: [Date]
- Prepared by: [Name, Title]
- Reviewed by: [Name, Title]
- Approved by: [Name, Title]
1. Introduction
1.1 Purpose
This Risk Management Plan establishes the framework for identifying, analyzing, evaluating, and controlling risks associated with [Device Name] throughout its lifecycle.
1.2 Scope
This plan applies to all phases of the device lifecycle from concept through disposal.
1.3 Regulatory Requirements
- ISO 14971:2019 - Medical devices - Application of risk management to medical devices
- [Additional applicable standards and regulations]
2. Risk Management Process
2.1 Risk Analysis
- Hazard identification
- Risk estimation
- Risk evaluation
2.2 Risk Control
- Risk control option analysis
- Implementation of risk control measures
- Residual risk evaluation
2.3 Risk Management File
- Documentation requirements
- Risk management report
3. Risk Acceptability Criteria
3.1 Risk Categories
- Negligible: [Define criteria]
- Acceptable: [Define criteria]
- Unacceptable: [Define criteria]
3.2 Risk Matrix
[Include risk probability vs. severity matrix]
4. Hazard Identification
4.1 Intended Use and Reasonably Foreseeable Misuse
- Intended patient population
- Intended user profile
- Use environment
- Operating principle
4.2 Characteristics Related to Safety
- Physical and chemical characteristics
- Infection and microbial contamination
- Environmental and test conditions
- Cleaning, disinfection, and sterilization
- Disposal and environmental protection
- Information supplied by manufacturer
5. Risk Analysis Worksheet
| Hazard | Hazardous Situation | Harm | P1 | P2 | Severity | Risk Level | Acceptability | |--------|-------------------|------|----|----|----------|------------|---------------| | [Hazard description] | [Situation] | [Potential harm] | [Probability of occurrence] | [Probability of harm] | [Severity level] | [Risk level] | [Acceptable/Unacceptable] |
6. Risk Control Measures
6.1 Risk Control Options (in order of preference)
- Inherent safety by design
- Protective measures in the device or manufacturing process
- Information for safety
6.2 Risk Control Implementation
[Document implemented risk control measures]
7. Residual Risk Evaluation
7.1 Individual Residual Risks
[Evaluate each residual risk against acceptability criteria]
7.2 Overall Residual Risk
[Evaluate overall residual risk and benefit-risk analysis]
8. Risk Management Report
8.1 Summary of Risk Management Activities
- Risk analysis completeness
- Risk control effectiveness
- Overall residual risk acceptability
8.2 Conclusion
[State conclusion regarding risk acceptability]
9. Post-Market Surveillance
9.1 Information Collection
- Adverse events
- User feedback
- Literature review
9.2 Risk Management File Updates
- Review frequency
- Update procedures