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Workshops & Conferences
This page provides information on public events that include CDRH participation which may be of educational value to the general medical device community.
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SCHEDULE FOR WORKSHOPS WITH CDRH PARTICIPATION
March 2008; April 2008; May 2008; June 2008; July 2008; August 2008; September 2008; October 2008; November 2008; December 2008
Date |
Event/Location |
Lead CDRH Office |
|
| March 10-12 |
AAMI's Software Validation Requirements and Industry Practice, Arlington, VA |
OC |
| March 17-19 |
AAMI's Design Control Requirements and Industry Practice, Arlington, VA |
OC |
| March 31-April 4 |
AAMI's Quality System Requirements and Industry Practice, St. Pete Beach, FL |
OC |
|
| April 4 |
FDA/ORA Dallas District Office and the FDA Medical Device Industry Coalition (FMDIC)'s ``Quality System Regulation Educational Forum on Design Controls,'' Dallas, TX |
ORA |
| April 8-9 |
The Essentials of Medical Device Regulations: A Primer for Manufacturers and Suppliers, Chicago, IL
|
ORA/OC/OCER |
| April 14-16 |
AAMI's Process Validation Requirements & Industry Practice, Arlington, VA |
OC |
| April 22-23 |
AMDM/FDA - OIVD 510(k) Workshop, Bethesda, MD |
OIVD |
| April 29 |
FDA/AdvaMed Workshop on Guidance for Coronary Drug-Eluting Stents: Non-clinical and Clinical Studies, Silver Spring, MD (Presentations available in PDF format) |
ODE |
|
| May 5-8 |
AAMI's Radiation Sterilization for Medical Devices, Atlanta, GA |
OC |
| May 12-14 |
AAMI's Integrating Risk Management into the Quality System, New Orleans, LA |
OC |
| May 13-14 |
The Essentials of Medical Device Regulations: A Primer for Manufacturers and Suppliers, Bethesda, MD |
ORA/OC/OCER |
|
| June 2-4 |
AAMI's Corrective and Preventive Action Requirements & Industry Practice, Arlington, VA |
OC |
| June 9-11 |
AAMI's Design Control Requirements and Industry Practice, Chicago, IL |
OC |
| June 16-20 |
AAMI's Quality System Requirements and Industry Practice, Denver, CO |
OC |
| June 17-18 |
The Essentials of Medical Device Regulations: A Primer for Manufacturers and Suppliers, Queens, NY |
ORA/OC/OCER |
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| September 8-10 |
2008 PDA/FDA Joint Regulatory Conference |
OCER |
| September 22-26 |
AAMI's Quality System Requirements and Industry Practice, San Diego, CA |
OC |
|
| October 2-3 |
FDA Workshop: Best Practices For Pacemaker and ICD Lead Postmarket Surveillance |
OCD |
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Additional Information on FDA Conferences and Meetings |
DSMICA - Division of Small Manufacturers, International and Consumer Assistance
OC - Office of Compliance
OCD - Office of the Center Director
ODE - Office of Device Evaluation
OCER - Office of Communication, Education, and Radiation Programs (Formerly OHIP)
OIVD - Office of In Vitro Diagnostics
ORA - Office of Regulatory Affairs
OSB - Office of Surveillance and Biometrics
OSEL - Office of Science and Engineering Laboratories (formerly OST)
For more information on these workshops contact the appropriate cooperating organization listed below:
| Organization |
Phone |
| AAMI - Association for the Advancement of Medical Instrumentation |
703-525-4890 ext.203 |
| AdvaMed - Advanced Medical Technology Association |
202-783-8700 |
| AMDM - Association of Medical Diagnostic Manufacturers |
202-637-6837 |
| ASQ - American Society for Quality |
800-248-1946 |
- Biomedical Division |
|
| FDLI - Food, Drug, and Law Institute |
202-371-1420 |
| MDM - Medical Design and Manufacturing Conference |
310-445-4200 |
| OCRA (Orange County Regulatory Affairs) Discussion Group |
949-222-9022 |
| RAPS - Regulatory Affairs Professionals Society |
301-770-2920 |
Updated August 14, 2008
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