Sundeep Agarwal

An expert in MedTech & Life sciences industry, Mr. Sundeep Agarwal is a speaker and trainer and Subject Matter Expert (SME) in the field of Regulatory Affairs, Quality Assurance, QMS, GMP, SaMD & Artificial Intelligence, Software Validation, IT Security & Cybersecurity, Design & development, Risk Management, Industrial Manufacturing and Clinical Studies.

He is a lead auditor for medical devices and has expertise in ISO 13485, 21 CFR 820, EU MDR/IVDR, CE Certification, PMS, FDA Approvals & MDSAP certification.

With more than a decade of experience and expertise, he serves regulators and industry professionals alike. He frequently contributes to global conferences in Europe, Canada and United States as speaker and panelist. A prominent guest lecturer in various MBA and Pharmacy educational institutions in India. He has delivered multiple global webinars for medical devices, diagnostics, and life science companies. These includes webinar for:

• American Society for Quality (ASQ Link: https://asq.org/quality- resources/webcasts)
• FDANews – fdanews.com
• QualityDigest – qualitydigest.com
• MedTech Intelligence – medtechintelligence.com
• Forum Institute – https://www.forum-institut.com/  Heidelberg, Germany

He is currently associated with Remidio (which is into SaMD & AI devices), India as Vice President – Regulatory Affairs & Quality Assurance, apart from being an active member of a technical committee (Work Group – Software as Medical Device) at Global Harmonization Working Party (www.ahwp.info/node/78).

Academically he holds a Master of Technology (Quality Management), an MBA, a Post Graduate Diploma in Medical Law & Executive Education on Quality Management and Manufacturing Strategy (Indian institute of Management), India.