Shweta Agarwal
Shweta Agarwal, Ph.D.
Dr. Shweta Agarwal brings over 15 years of expertise in biomedical engineering and medical devices. She partners with MedTech leaders and startups to advance clinical excellence, regulatory compliance, and patient safety. Shweta is an ISO 13485 Lead Auditor and supports product launches across medical devices, digital health, IVDs, combination products, and emerging frameworks such as the EU AI Act, with a focus on US and EU markets. Her work spans the full lifecycle, from regulatory strategy, US 510(k) and EU MDR/IVDR submissions, to clinical evaluations, Notified Body Opinions under Article 117, coordinated assessment procedures, and PMS/PMCF planning. Shweta also contributes to global standards development through the ISO CH 210 committee for medical devices.