Dr. Jaishankar Kutty Joins RQM+

February 1, 2021 - RQM+ welcomes Dr. Jai Kutty.

BSI Leadership Roles

Jai joins RQM+ after seven years at BSI where he held CE marking technical and clinical leadership roles. He presents a unique blend of expertise combining cardiovascular product development and CE marking leadership with a keen appreciation for the rapidly evolving medical device regulatory landscapes.

At BSI, Jai successfully trained and developed a structural heart team of multiple technical experts that have successfully CE marked some of the most innovative cardiovascular technologies.

Clinical Expertise

A multicultural upbringing and an international education have instilled an accommodating global outlook into Jai, with a creative bent leading to a portfolio of simple technical solutions to complex engineering and clinical problems.

Jai’s comprehensive cardiovascular device experience spans product development, advanced biomechanical testing, preclinical model development, physician training, FDA interactions, implantable device commercialization, and patents. His technical forte includes a solid grasp of device design features, key clinical challenges, and clinical outcomes of multiple transcatheter technologies.

Previously, his award-winning doctoral dissertation research in tissue engineering focused on developing vocal fold wound healing paradigms at Clemson University has resulted in multiple peer-reviewed publications in high impact factor journals with 500+ citations and an NIH grant (for the PI).

The RQM+ Clinical Services team has a unique combination of clinical and regulatory expertise. Led by Dr. Amie Smirthwaite, recent Global Head of Clinical Compliance at BSI, we provide an accurate assessment of sufficient clinical/performance data and effective strategies for filling the gaps to enable CE marking to MDR and IVDR.

RQM+ CERs and PERs are like no others because we focus on balancing regulatory and business objectives and providing notified bodies with the cohesive story and data that makes for an easier review and fewer questions. The addition of Jai will further strengthen this team and success for our clients.

Core Values

Jai’s dependable strengths include uncompromising integrity, analytical thought, boundless energy, critical foresight, and sound judgment towards complex clinical regulatory strategy related issues.

An engaging communicator with a tactful approach to problem-solving spanning device development/testing and regulatory/clinical strategy, he is dedicated to helping people and excited to begin working with RQM+ clients.

Where to find Jai

Jai will be featured in our upcoming RQM+ Live! shows:

• February 11, 2021 – Overcoming Challenges with integrating PMS, CERs/PERs and Risk Management under EU MDR and IVDR

• February 25, 2021 – The surprising true cost of submitting non-compliant technical documentation to notified bodies

These panel discussions are an excellent way for you to get to know Jai and hear his interpretations and perspectives. Subscribe to our blog to receive alerts on these and other RQM+ events.

Welcome, Jai Kutty!

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