Residual Risk and Risk based Verification
Overview:
Learn how define the residual risk of your device and how to streamline the verification process by employing a risk based approach.
Adjusting the verification process to account for the criticality of the verified items can drastically reduce the overall cost and time for verification activities. By implementing a risk based verification approach activities at the end of the device development can be streamlines and the time to market can be shortened without compromising the safety or effectiveness of the medical device.
Areas Covered in the Session
- Residual risk identification and declaration
- Risk based verification techniques
- Objective base verification planning
- Documentation of verification activities
- Practical tips for verifying system and software requirements
Who Will Benefit:
- Project Managers
- System Engineers
- Test and Verification Engineers
- Regulatory Affairs
- Compliance Managers
- Regulatory and Compliance Associates