February 17, 2011
Medical device companies require a deep understanding of the process, and a comprehensive set of capabilities to avoid the increased costs, schedule delays, and FDA regulatory problems resulting from gaps in the development process.
The speakers highlight their experiences in this field from multiple points of view. Mark Brinkerhoff and Walt Maclay share their product design / prototype development perspectives. To round out the discussion, Rajan Patel, an entrepreneur who has managed many projects provides the viewpoint of an active growing technology based medical device company. You will learn more about:
• Identifying the gaps
• Setting up an FDA compliant design control process
• Product Verification and Validation (V&V)
• Avoiding problems with the FDA
• Project Management
If you are currently engaged in the development of technology based medical products, and are interested in learning from industry experts how you can improve your design practices, and learn more about how to identify and fix the gaps in your process, then this resource is for you.
Presenters:
Mark Brinkerhoff, President, Fusion Design
Walt Maclay, President, Voler Systems
Rajan Patel, Serial Entrepreneur