14 years of experience in Product Management, Clinical Research, Usability testing of medical devices. Hands on experience in product development and testing. Subject matter expert in preparing, guiding on Clinical Investigation strategy as per ISO 14155, Annex XV of EU 2017/745 requirements, Post market Surveillance & Post market clinical follow-up as per Annex XIV Part B of EU 2017/745, MDCG 2020-7, MEDDEV 2.12/2 rev 2, NB-MED/2.12/Rec1, ISO TR 20416 requirements for the clients. Works as Vice President managing clinical projects, timelines for the project, documentation closure, and submission to notified bodies. Rich experience in report generation such as Clinical Investigation Report (CIR), Periodic Safety Update Report (PSUR), Post Market Surveillance Report (PMSR), Post Market Clinical Follow-up Report (PMCFR) in alignment with relevant stakeholders. Certified ISO 13485 Lead auditor from BSI.

SERVICES:
• Clinical Evaluation Report (CER)
• PMCF
• SSCP
• PSUR
• CIR