Author name: Mita Mistry

Mita Mistry leads regulatory strategy at Regulatory Frontier, a consultancy focused on medical device quality and regulatory affairs. She works across FDA 510(k) and De Novo pathways, EU MDR technical documentation, and CDSCO licensing in India, with hands-on experience in ISO 13485 quality systems, IEC 62304 software lifecycle, and clinical evaluation. Her writing translates new regulations and draft guidances into practical steps for device teams.