Post-Design Medical Device Risk Management - Webinar by GlobalCompliancePanel
Venue: Online Training Webinar
|Event Date/Time: Sep 07, 2010||End Date/Time: Sep 07, 2010|
|Registration Date: Sep 06, 2010|
|Early Registration Date: Sep 06, 2010|
Why Should You Attend: Medical device companies have done some form of design risk management for many years, although with the introduction of ISO 14971, the techniques have evolved and improved. The area of Post-design Risk Management is new to the medical device world with the introduction of ISO 14971. Companies are attempting to interpret and apply these new requirements with mixed results. In addition are the changing requirements of regulatory bodies in the postmarket phase of the device lifecycle.
Areas Covered in the Session:
* What does Clause 9 mean for the medical device manufacturer?
* Use of the Risk Management File after design
* When to update the Risk Management File
* How does the Risk Management File interface with CAPA?
* What about changes in design of product after release?
* How do process changes impact the Risk Management File?
* Why audit the Risk Management File post-design?
* Why does Management Review need to look at post-design Risk Management?
Who Will Benefit:
* Risk Managers
* Quality Engineers and Managers
* Process Engineers
* Product Maintenance Engineers
* Quality Managers
* Regulatory Affairs
* Product Managers
* Internal and External Auditors