White Paper: The Real Cost of Noncompliance

Leveraging IVDR for Long-Term Savings in the MedTech Industry 

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 HeadshotMARGOT BORGEL, Ph.D. 

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.

jon gimbelJONATHAN GIMBEL, Ph.D. 

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+.



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