Shweta Agarwal

Regulatory & Safety Specialist at EY

Shweta Agarwal is a Manager in the EY Global Life Sciences Practice, with 10 years of experience in biomedical engineering and medical devices. She is an experienced MedTech life sciences consultant and with a passion for clinical, quality and patient safety for medical & pharmaceutical technologies.

Prior to EY, Shweta was a Managing Consultant in a global mid-sized consultancy’s Life science practice. Her expertise is in the design and development activities of medical devices, drug-device combination and software products. She advises manufacturers seeking regulatory & commercial assessments and compliance with medical standards and regulations globally, focusing on the US and EU. She has experience in reviewing records, preparing regulatory documentation, formulating submission & auditing strategies. Shweta has worked with EU notified bodies to review clinical reports of device manufacturers for CE certification. She also has first-hand pre-clinical trial experience per Good Laboratory Practice (GLP) across the US and EU. She specialises in developing technical design dossiers, clinical evaluation reports, risk management files and post-market safety reporting.

Shweta has a PhD in Biomedical Engineering & Material Sciences from Imperial College London. She was a former research scholar at Harvard Medical School (Brigham and Women’s Hospital) and currently holds an Honorary Research Associate position at University College London. She also serves as a Committee member at BSI for medical devices (CH/210) and in vitro diagnostic devices (CH/212), contributing to the development of medical standards.