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 technologies. Her expertise is in the regulatory and 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 (MDR and IVDR). 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, performance/clinical evaluation reports, risk management files, post-market safety reporting, formulating submission & auditing strategies and remediation activities.