Quality Systems Regulation Educational Forum on Design Controls

The goal of this educational forum was to present information that will enable manufacturers and regulated industry to better comply with the Medical Device Quality System Regulation (QSR). The following topics were discussed:

1. Design Control Overview and Planning
2. Design Inputs and Outputs
3. Design Verification and Validation
4. Design Transfer
5. Design Change
6. Design History Files

We suggest you read Design Control Guidance For Medical Device Manufacturers to learn more on the above subjects.

When and Where

This educational forum was held on April 4, 2008, from 8 a.m. to 5 p.m., in Dallas, Texas.

Registration

Registration is closed.

Discounted fees for government employees and students required positive identification documentation presented at the door on the day of the event. The registration fee was used to offset expenses of hosting the event, including continental breakfast, lunch, refreshments, meeting rooms, and materials.

Special Accommodations

If you need special accommodations due to a disability, please contact David Arvelo at least 21 days in advance:

David Arvelo
Small Business Representative
Food and Drug Administration
4040 North Central Expressway, Suite 900
Dallas, TX 75204
Phone 214-253-4952
FAX: 214-253-4970
Email david.arvelo@fda.hhs.gov

Correction

The Federal Register of October 11, 2007 (72 FR 57951) stated that this event would be held at the Omni Mandalay Bay Hotel in Las Colinas, Texas. Note that we've changed the venue and is now the Adam's Mark Hotel Dallas, 400 North Olive Street, Dallas, TX 75201, (214) 922-8000 (72 FR 70873).

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Last modified: 02/26/10