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San Francisco Bay Area Chapter Webcast: Driving Innovation through Changes to FDA Medical Device Regulations

RAC Credits
Friday, 06 November 2020 (8:00 AM) - Friday, 06 November 2020 (9:30 AM) Pacific Time (US & Canada)

Member: FREE
Nonmember: $20

Your participation in the regulatory community is vital. Currently, RAPS Chapter in-person events are converted to webcasts so that regulatory professionals have online access to valuable knowledge necessary to understand the daily impact on our industry. RAPS is offering this webcast for free to members and $20 for non-members.


The focus of this webcast is to discuss the need for updating your regulatory strategy to adapt to the changing regulatory landscape for the development of safer, more effective medical devices. As a part of the Safer Action Plan for Medical Devices, FDA is updating and enhancing the 510(k) and De Novo review processes, has finalized guidance on the Breakthrough Device Program and is adding a new Safer Technologies Program (STeP). Medical Device manufacturers must have a firm understanding of these different regulatory pathways to help guide product development and accelerate commercial clearance for increased patient access to innovative medical devices in the United States.

Who Should Attend?

Medical Device Manufacturers who want to stay current on recent regulatory trends that affect their products, Regulatory Affairs professionals new to the 510(k) and de novo processes, Regulatory Project/Program Managers responsible for product development plans and timelines, Clinical Affairs professionals responsible for clinical testing of medical devices, and Quality Assurance professionals overseeing product development of medical devices in the United States. 

Learning objectives:

After attending this webcast, you will be able 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

The webcast will conclude with a Q&A session. 

This event is brought to you by the RAPS San Francisco Bay Area chapter to encourage knowledge sharing and community development. RAC holders may claim 1.5 RAC recertification credits.

Learning Level: Basic

Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.

This webcast is available to RAPS members for free. RAPS membership provides vital information for regulatory professionals and a place for networking and invaluable connections. Now is a great time to explore the many benefits to RAPS membership, including the Member Knowledge Center and our award-winning, private online community, Regulatory Exchange. 

Find out more about RAPS membership today.

How Do Webcasts Work?

For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. A live Q&A portion with the speaker will follow the presentation.

Featured Speaker:
Chris Thierfelder, project management consultant, Integrated Project Management Company, Inc. (IPM)