The compliance dates for the European Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) are quickly approaching. In response, Treximo is hosting a webinar series that will cover a wide variety of pertinent subjects applicable to the device / diagnostics industries as they relate to the change in the regulatory framework in Europe.
The fourth training in our series was held on March 23, 2021 and focused on “The Top Considerations an EU MDR / IVDR Project Lead Should Have (Before / After Implementation).” Treximo’s VP of Life Sciences Consulting Rob Turner presented the session.
A full recording of the webinar can be accessed below.
In the training, Rob discussed how although learning and understanding the regulation is one extremely important and critical goal, knowing how to take that information and effectively drive an IVDR / MDR project to completion is another necessary and complementary element.
Rob’s presentation also covered various hurdles from kick-off to sustainability along with some recommendations on how to address those challenges. He also provided a review of the unique project management components that are apt to arise throughout implementation of an MDR or IVDR program, including what each means, how each is unique to MDR / IVDR, how to address each area and what happens if these steps are ignored:
- mobilize project
- process impacts
- technology impacts
- roles & responsibilities
- partner alignment
- regulatory intel effort
- certification preparedness
Part five of the series will be Tuesday, May 18th and feature “A Roadmap for a Successful IVDR Transition: a Cross-Functional Discussion with Key Focus Areas.” Register here.