The 3 Big Drivers Accelerating Change in MedTech
By Carl Manthe, Director and Medical Technology Industry Lead, Integrated Project Management Company, Inc. The U.S. MedTech industry is a dynamic and rapidly evolving landscape,…
The good news is that the FDA is enhancing review processes to ensure medical devices are safer and more effective. But are your new products and procedures ready for the updated 501(k) and De Novo regulations?
Your company and its customers depend on you to stay on top of the changing regulatory landscape to guide product development and accelerate commercial clearance for innovative medical devices. However, studying new guidelines and review processes is a to-do item that rarely reaches the top of the list.
This webinar on the FDA’s latest thinking on regulating Class II medical devices was hosted on November 6, 2020 by the San Francisco Bay Area Chapter of RAPS and presented by IPM Project Management Consultant and medtech veteran Chris Thierfelder. The video will enable you to:
- Understand the 510(k) requirements and plan for submission
- Determine if clinical trial testing will be needed for your product
- Adjust your product development plans based on a robust risk analysis