Varun Sukumaran

Varun is an Ex- Notified Body technical and QMS assessor, and is an experienced trainer. With experience gained within a variety of organizations from small companies to large corporations situated across Europe, US, Australia and Japan, Varun has dealt with active devices, non-active devices, Drug-device combination products and software devices in the forms SaMD, SiMD and MDSW. With the deep knowledge and expertise in the Digital Health, Varun has advised numerous MedTech companies on regulations and route to market strategies for their software based products. With the past experience at CRO and Notified Body, Varun has also a strong expertise in reviewing and creating clinical documentation for Medical device regulatory approval in the EU and US.