by
Markus Weber
Overview: The presentation provides practical tips to comply with ISO14971, implement risk management, and minimize the administrative burdens imposed to handle the additional process.
Learn how to put an effective risk management plan in place and fulfill the requirements of ISO14971
In the medical device development process, it has become a regulatory necessity to implement an effective risk management plan to fulfill the requirements of ISO14971. Manufacturers, however, still struggle to comply with ISO14971 and find a meaningful way to introduce risk management to the overall operating framework.
Areas Covered in the Session:
- Basic principles of risk management
- Risk management planning and procedures
- Hazard and risk analysis
- Documentation of risk management activities
- Practical tips for implementing risk management processes
Who Will Benefit:
- Project Managers
- System Engineers
- Regulatory Affairs
- Compliance Managers
- Regulatory and Compliance Associates