Design Transfer: Best Practices for the Successful Transfer of Medical Devices from Research and Development to Manufacturing
A common and continuing challenge for medical device companies is the transfer of products from the research and development design phase to the manufacturing/production phase. Without an effective design transfer process, there are many potentially serious business–related and regulatory problems that medical device manufacturers might encounter. Organizational inefficiency, delayed product launch, poor product quality, and regulatory/compliance concerns are examples of negative consequences of a poorly planned and executed design transfer process. Addressing these types of problems that continue to be a concern for most companies, program speakers presented a wide-ranging perspective on the best practices available for implementing an effective Design Transfer system.
TOPICS COVERED
- Quality System Regulation and ANSI/AAMI/ISO 13485:2003 Requirements for Design Transfer
- Standard Terminology
- Timing of Design Transfer with Process Validation
- Discussion of Best Practices
- Design Transfer and Contract Manufacturers
- Developing a Useful Design Transfer Checklist
SPEAKERS
- Vera Buffaloe, Buffaloe Consulting Inc.
- Jack Ward, Ward Sciences and Consulting, LLC
CD FEES
- $295 for webinar registrants
- $395 for non-registrants
- Includes handout material and CD.
- Please note: Domestic and international shipping rates apply.
THREE WAYS TO ORDER
- Phone - 1-877-249-8226 or 240-646-7031 to order with a credit card.
- Fax - Select and download the order form and fax to 240-396-5781 .
- Mail - Select and download the order form and mail with payment to:
Design Transfer CD Package
AAMI Publications
PO Box 0211
Annapolis Junction, MD 20701-0211
Arlington, VA 22201-4795
QUESTIONS?
For
questions about ordering the CD, please contact Publications at 1-877-249-8226 or 240-646-7031.