Apoorva Rama

Apoorva has 8 years’ experience in the medical device industry and is Team Lead in the Medical Devices Team at Celegence. She manages documents for regulatory submissions and ensure compliance across multiple regions, including the EU, US, and Saudi FDA. She has authored and reviewed technical files, GSPRs, risk documents, QMS documents and various gap assessments for global regulations and standards. She also has extensive experience with ISO 14971 risk documentation and ISO 13485 quality management system. In addition to regulatory submissions, she supports regulatory intelligence projects, offering strategic insights into evolving medical device standards and regulations.