The inherent complexity of IVDR has left many organizations grappling with implementation issues. Despite these challenges, IVDR compliance can yield substantial long-term cost savings for MedTech companies.
This paper explores what IVDR means for the MedTech industry and provides insights on turning compliance into a strategic advantage.
What IVDR means for your business
Real-world case studies exploring how manufacturers overcame common IVDR challenges
Lessons for minimizing IVDR costs and accelerating time-to-market
The long-term financial rewards of IVDR compliance
MARGOT BORGEL, Ph.D.
DIRECTOR, IVD INTELLIGENCE AND INNOVATION
Margot Borgel is an IVD expert at RQM+ who helps her clients in many ways, primarily with IVDR implementation and notified body requirements. Prior to RQM+, Margot was a Technical Specialist at BSI, where she performed technical reviews for IVDR, IVDD, and UKCA certification. She's especially passionate about certification of high-risk devices and enjoyed seeing these devices through IVDR certification while at BSI. Before her notified body work, Margot worked for an IVD manufacturer where she held roles in R&D, manufacturing technical support and manufacturing.
JONATHAN GIMBEL, Ph.D.
VICE PRESIDENT, TECHNICAL
Dr. Jonathan Gimbel joined RQM+ in July of 2014. He has a Ph.D. in Mechanical Engineering from the University of Pennsylvania and is a clinical and regulatory affairs expert with over 20 years of experience in medical devices. Jonathan has a wide variety of clinical and regulatory experience as an academic researcher, key member of a medical device startup, and medical device consultant. This has given him extensive knowledge of biomedical research, new product development, quality systems, FDA and EU regulatory affairs, clinical evaluation, and post-market surveillance activities. Jonathan is currently the Vice President, Technical within RQM+’s consulting services. In this role, he is actively involved in overseeing the technical aspects of the regulatory, quality, clinical evaluation, and post-market practices at RQM+.