VP, Intelligence and Innovation
RQM+
Dr. Jaishankar ("Jai") Kutty presents a unique blend of expertise combining cardiovascular product development and CE marking (technical & clinical) leadership with a keen appreciation for the rapidly evolving cardiovascular
device and medical device regulations landscapes. His comprehensive cardiovascular device experience spans product development, advanced biomechanical testing, preclinical model development, physician training ,
FDA interactions, implantable device commercialization and patents.
In January of 2021, Jai joined RQM+ as the VP of Clinical and Post-Market Practice. In this role, Jai provides leadership and technical support to both RQM+ clients and internal teams with the interpretation and implementation of EU medical device regulations. Jai’s deep technical and clinical understanding of devices combined with his extensive regulatory knowledge and notified body insight make him a fantastic leader at RQM+.
Over the past seven years he has held CE marking technical and clinical leadership roles at BSI. He has been involved in biological safety evaluations via chemical characterization and biological endpoint-based biocompatibility testing, both as part of industry and as a CE marking technical expert at BSI. His industry experience involving biological safety evaluations spans chemical characterization activities in St. Jude Medical Inc.’s (now Abbott Medical) analytical chemistry lab and the development of biocompatibility strategies supporting regulatory submissions for heart valve repair/replacement products, across multiple geographies. At BSI, he has reviewed numerous submissions involving biological safety evaluations and has trained several technical team members on the nuances of biocompatibility assessments and the ever-evolving ISO 10993 standards.
Disclosure information not submitted.
Monday, September 12, 2022
2:00 PM – 3:00 PM MST