With a majority of FDA recalls attributed to human factors or use error, managing risk through traceability is vital to the success of medical device development. Mitigating design-related problems that contribute to unsafe or ineffective use is critical to overall risk management and speed to market.
Watch Jama Software and medical device user-research experts Bresslergroup, in the recorded virtual event, Accelerate Medical Device Development While Reducing Risk. We discuss ways to free your teams from document-based requirements management and streamline processes, allowing them to spend more time on innovation.
Experts from Bresslergroup’s Human Factors and User Research Team will share best practices and case studies to help uncover risk and improve product performance. Jama Software’s experts will also demonstrate how Jama Software helps medical device developers manage requirements, risk, testing and project volatility to ease the path to compliance.
We’ll cover how you can:
- Build a robust usability engineering plan based on regulatory guidance and medical device industry best practices
- Learn from Bresslergroup’s field experience on human factors and user testing
- Identify and trace requirements related to usability
- Discover hazards and hazardous situations related to usability
- Analyze residual risk associated with usability
- Meet ISO 62366 and FDA draft guidance for applying human factors