Mr. Shivkumar Hurdale

Mr. Shivkumar Hurdale

 Mr. Shivkumar Hurdale holds the position of Senior Director - Regulatory Affairs, Quality Assurance, Asia Pacific. In this role, he provides regulatory strategic leadership support for all Asia Pacific countries including India for MedTech Business .


Shivkumar is a Pharmacist, certified ISO 13485:2016 Lead Auditor and has completed Global Internationally Certified course in EU MDR from Oriel STAT A MATRIX, New Jersey, USA. Mr. Hurdale holds a Post Graduate degree in Pharmaceutical technology from Vinayaka Missions Research Foundation, Hyderabad.


Shiv has worked with Johnson & Johnson, Medtronic, Abbott and Novartis Healthcare. He has more than 16 years of experience in Manufacturing, Quality, Standards & Regulatory in single use, In-vitro, combinational Medical devices and Pharma products in India, ASPAC and USA region.


Shiv has successfully held workshops for the training of the Standard authorities, regulators and regulatory authorities at centre and state level in India and Sri Lanka. Shiv represents Industry in Bureau of Indian Standard meetings and deliberates on upcoming regulations and regulatory reforms, Standards for Medical Devices in the India.


Shiv also represents Bureau of Indian Standards (BIS), Govt of India in ISO TC/150 Technical Committee.


Mr. Shivkumar has Chaired and Co-Chaired Regulatory and Advocacy Sub-committees of Medical Devices in CII, FICCI


Mr Shivkumar is Vice-Chair of MTaI (Medical Technology Association of India) and APACMed GA Committee (The Asia Pacific Medical Technology Association) represents manufacturers and suppliers of medical equipment, devices and in-vitro diagnostics, industry associations and other key stakeholders associated with the medical technology industry in Asia Pacific.