This is another installment of FMDIC's wildly popular series of education forums on the medical device Quality System Regulation (QSR) mandated by Title 21 of the Code of Federal Regulations, Part 820 (21 CFR 820). We will post the agenda and speakers very soon.

The goal of the workshop is to present information that will enable manufacturers and regulated industry to better comply with the Medical Device QSR. The following topics will be discussed at the workshop:

1. standards and guidance
2. risk management in design
3. risk management in execution
4. risk management and post market surveillance

Date: Friday, April 2, 2010

Time: 8:30 AM to 5:00 PM

Venue: The New Cowboys Stadium in Arlington, 925 North Collins Street, Arlington, Texas [Directions]

Notice of Public Workshop