Varun SukumaranAssociate Director, Life Sciences at Guidehouse
Varun has over 14 years of regulatory and industry experience working with medical device clients. He has deep expertise in the areas of regulatory strategy development and strategic product launch planning, product technical evaluation and post-market assessment. Varun is a qualified technical and QMS Notified Body auditor and has conducted various training sessions on European regulations.
He is a subject matter expert on medical device regulations(MDR) and Medical device directive (MDD) in the Europe for Class IIa, IIb and III devices, including devices incorporating software, drug-device combination devices and stand-alone software devices
Through the experience gained at CRO and Notified Body, Varun has a strong background in reviewing and creating clinical documentation for regulatory approval in the EU and US. His expertise also includes creating regulatory road map from the device concept stage to market launch.
Prior to joining Guidehouse, Varun was a Senior strategy consultant at Icon PLC for medical devices. He has previously served as a lead auditor at a Notified Body(BSI) in the UK and worked at a safety test house(Intertek) as a Senior Compliance Engineer.
Mr. Sukumaran received a Master of Electronics degree in Circuit Design from the University of Dundee, and a Bachelor of Engineering in Electronics and Communication from the Anna University, India.