The compliance dates for the 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 fifth training in our series was held on May 18, 2021 and focused on “A Roadmap for a Successful IVDR Transition.” Moderated by Treximo’s SVP of Device and Diagnostics Ron Freeze, the panel included Rob Turner, Treximo’s SVP of Life Sciences Consulting; Bobbi Druyor-Sanchez, Partner and Expert Consultant, NDA Partners; and Cortez McBerry, Regulatory Consulting Director, NDA Partners.
A full recording of the webinar can be accessed below.
The participants discussed the final 12 months before the IVDR date of application along with how to identify and plan for a transition from IVDD to IVDR and ways organizations can successfully manage the transition. Also covered:
- Technical Files – avoiding and disarming traps
- Quality Systems – audit strategies to prepare for the transition
- Lessons Learned – what manufacturers need to consider to avoid issues identified by MDR manufacturers
- Preparation and Continuation – different tools available for navigating the transition and for continued success post-transition
- Choosing New Classifications
Download a copy of the slides here.
For a copy of our IVDR Timeline Checklist, contact us.
Part six of the series will be held in September. More information will be available on our website. Check back for details!