Regulatory Roundup by MassMEDIC

A virtual Regulatory Roundup, designed to give RA, QA, and C-level executives updates on the industry's global and domestic regulatory issues.

Learn from comprehensive presentations by CDRH, industry representatives and regulatory experts

9:00 – 9:45 AM Destination, Switzerland? The Impact of the Recent Decision of the Swiss Parliament on Medical Devices with FDA Authorization


Switzerland's Parliament has recently decided to mandate the Swiss government to adapt the national law so that in the future medical devices with FDA Authorization will be recognized in Switzerland in addition to CE-marked medical devices. Joining us from Switzerland’s association of medical technology, Swiss Medtech, is Sandra Rickenbacher-Läuchli, Head of Public Affairs & Legal Counsel, Member of the Executive Board, to discuss this pioneering decision. Sandra will speak about the implementation of the decision, the way forward as well as discuss potential impacts for global and domestic companies moving forward.
9:45 – 10:30 AM Where We Are with MDR
 
10:30 – 11:00 AM FDA Priorities for 2023
 
11:00 – 11:20 AM Recent Developments on the “Fraud on the FDA” Theory of False Claim Liability

Rick Ball and Coleen Hill from Duane Morris will provide an overview of a theory of liability for pleading claims under the False Claims Act commonly referred to as “Fraud on the FDA.” They will discuss what risks such a theory might pose and delve into how various federal courts have recently accepted or rejected claims based on this theory.  
 
11:20 – 11:45 AM Cybersecurity Best Practices for Regulated Medical Devices
 
11:45 AM – 12:30 PM Keynote Presentation & Q&A - Dr. Suzanne Schwartz, Director, Office of Strategic Partnerships and Technology Innovation, CDRH, FDA
 
This session will provide an overview of the latest updates from CDRH’s Office of Strategic Partnerships and Technology, with a specific focus on digital health and cybersecurity. This briefing will be followed by a moderated Q&A session led by Amra Racic of Veeva Systems where you will get the chance to ask your questions directly to Dr. Schwartz!
 

 

We'll be at the event:

Milo Baker Portrait
Milo Baker
Project Manager USA
Lukas Sieber Portrait
Lukas Sieber
Executive Director USA

Contact us

Can we put you in touch with a peer company or research institute? Do you need any information regarding your strategic expansion to Switzerland's technology and business center?  
info@greaterzuricharea.com