Jaishankar Kutty, PhD

Vice President, Regulatory, Reimbursement, & Market Access

With over 16 years of distinguished experience in the medical device industry, Jai brings robust expertise in R&D, clinical, and regulatory leadership from roles at BSI and St. Jude Medical to his position at RQM+. At RQM+, he leveraged EU-notified-body expertise to guide manufacturers through complex clinical and regulatory landscapes, specializing in clinical/regulatory strategy, clinical study design, retrospective data gathering, biological safety evaluations, interaction with regulatory agencies, and benefit-risk analyses. Jai ensures rigorous compliance and drives advancements in evidentiary foundations for legacy devices. At BSI, he spearheaded CE marking for cutting-edge cardiovascular technologies and played a critical role in securing MDD re-designation for the UK and achieving MDD/MDR designations for Dutch notified bodies. Jai contributed to groundbreaking advancements in surgical and transcatheter heart valve technologies, including innovations in septal closure, vascular closure, and renal denervation, setting new benchmarks for R&D and clinical excellence.​