The presentation is conceived as a practical demonstration of how to meet post-design requirements of ISO 14971. We will review the production and post-production requirements of ISO 14971 as stated in Clause 9 and interpret their meaning for the medical device industry. The presentation will use practical examples of the application and use of risk management information as well as determine when risk management files need to be updated. We will also review the requirements for Management Review of risk management activities in the post-design portion of the product lifecycle, and present examples of how to meet these requirements.

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