Dr. Selva

Director-Quality and Regulatory at SigTuple

Dr. Selva has worked in various roles in the medical device industry since 2002. Starting as a Technical Officer at Ventri Biologicals, they then moved on to become a Production Manager at Bharath Biotech Group in 2006. In 2009, they were Head of Manufacturing at Stempeutics Research (P) Ltd. In 2015, they became Vice President of Operations at Axio Biosolutions Private Limited, where they were responsible for the implementation of QMS as per ISO 13485:2016 and getting 510K and CE approval for the devices. In 2019, they held the role of Associate Director of Quality and Operations at LifeSignals Inc. In 2020, they became a Principal Consultant of the Medical Devices QARA Practice at Tech Mahindra, where they were responsible for the Quality and Regulatory services management for their MedTech Clients. Currently, they are Director of Quality and Regulatory at SigTuple, where they are responsible for QMS implementation as per ISO 13485, 21 CFR Part 11 requirements, and the regulatory strategies and approval process of their AI-based devices for various markets including the USFDA, EU, India, and other emerging markets.

Dr. Selva began their education in 1986, when they attended Government High School in Aniyapuram and obtained their SSLC in Science. In 1991, they moved to Government Higher Secondary School in Mohanur and obtained their Higher Secondary in Science. Dr. then attended Tamilnadu Veterinary University, where they obtained their M.V.Sc in Veterinary Microbiology in 2002. In 2013, they attended Manipal University and obtained their Master of Business Administration (M.B.A.) in Operations Management in 2015. In 2014, they obtained a Six Sigma -Green Belt certification from Exempler Global.

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  • Director-Quality and Regulatory

    October, 2022 - present