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Risk Management
Risk management involves the identification, understanding, control, and prevention of failures that can result in hazards when people use medical devices. Hazard Analysis, risk analysis and xFMEAs play a key role in the development of medical devices design.
Learn more about our Capabilities
At Pivotal, we are seasoned practitioners of risk controls, developing and implementing processes prior to the advent of ISO 14971. Our methods and process involve the identification and control of harm to prevent failures that can result in hazards to those using medical devices. Hazard Analysis, Risk Analysis and xFMEAs for use and cybersecurity are important considerations in medical device design which are verified and validated through testing and user studies.
Areas of Expertise:
- Develop Risk Management Plan
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- Essential Performance
- Software and product classification
- Intended use
- Foreseeable misuse
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- Perform Risk Management and Usability
Engineering Activities and Reviews
- Establish risk acceptance criteria
- Hazard Analysis – system
- Hazard Analysis – user
- Risk Analysis
- xFMEA
- Risk Management Report
- Risk Management File
- Cybersecurity per 2022 draft guidance for Cybersecurity in Medical Devices addressing
- Authenticity
- Authorization
- Availability
- Confidentiality
- Update
- We deliver
- Security Plan
- Security Architecture to identify vulnerabilities
- Risk Analysis addressing factors such as Impact, Exploitation
- Security controls for authentication, encryption, integrity
- Methods for secure FOTA (Firmware Over The Air)
