Elisuba Philipose

Conducted literature screening and data extraction for neuromodulation device to support MDR clinical evaluation. Benchmark comparator device safety/performance and defined preliminary clinical endpoints. Identified key clinical risks and gaps to inform Clinical Investigation design.

Led annual regulatory updates of CEP and CER for Class III orthopedic implants, ensuring adherence to EU MDR requirements. Critically appraised clinical evidence, developed detailed evidence tables, and managed documentation integrity. Successfully addressed all Notified Body queries, securing timely approvals and maintaining compliance status for multiple product families. Mentored junior writers on regulatory documentation best practices and technical quality standards.

Developed and reviewed CEP/CER for ophthalmic medical devices, ensuring compliance with EU MDR. Executed systematic literature searches and data summarization to construct strong clinical arguments

Developed and maintained CEP and CER for critical Class III cardiovascular devices (stents and catheters). Performed clinical literature mapping and regulatory gap analysis crucial for the EU MDR transition

Managed all Quality Assurance documentation, ensuring compliance with ISO 13485 and IVDR for IVD devices and reagents. Implemented and tracked Corrective and Preventive Actions (CAPA) and managed nonconformance reports. Controlled SOP and BMR documentation, maintaining version control and ensuring QA approval. Reviewed and approved artworks, pack inserts, and labeling content for adherence to regulatory standards