White Paper: Strategy for Leveraging Chemical Characterization & Toxicological Assessments Towards Biological Equivalence

Demonstrating biological equivalence can be challenging, but the investment often pays off because you can save time and resources by leveraging existing clinical data. Understanding what notified bodies expect to see when it comes to establishing biological equivalence is the first step in creating an acceptable rationale. Fortunately, with former notified body leaders on our team, RQM+ has unique insights into these expectations, and we share them through free resources such as this white paper. 

Written by RQM+ Vice President of Intelligence & Innovation Jaishankar (Jai) Kutty, Ph.D., Strategy for Leveraging Chemical Characterization & Toxicological Assessments Towards Biological Equivalence follows up on his first paper and includes:

  • Which ISO 10993 standards are relevant to biological equivalence
  • Key steps for chemical characterization and toxicological risk assessment 
  • How to use chemical characterization towards establishing biological equivalence
  • And much more!

Download the paper today to learn how to establish biological equivalence for your medical devices under EU MDR. 

Meet the Author

jai_kutty-1Jaishankar (Jai) Kutty, Ph.D.

RQM+ Vice President of Intelligence & Innovation

Dr. Jaishankar "Jai" Kutty joined RQM+ in February 2021 after seven years at BSI, where he held CE marking technical and clinical leadership roles. Jai leverages his unique blend of expertise combining cardiovascular product development and CE marking experience toward supporting our clients with regulatory solutions and developing clinical strategies. His fresh-from-the-notified body perspective brings great insights and creative approaches to our clients.

"The paradigm shift in EU regulatory/clinical is real, but it isn’t quite like mapping Mars either. Along with the talented, knowledgeable team at RQM+, I’m committed to helping retain legacy devices on the market and ensuring patients can benefit from innovative technologies.”

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“Together you all moved the mountain. I am greatly appreciative and humbled by all of your commitment to excellence. Thank you for all you have done for [our company].”

MDR submissions senior manager

Large multinational medical device manufacturer