Manikumar T
Lead Engineer -PMS l Data Analyst l Medical Device Complaints l QA/RA l ISO 13485: 2016 l Risk Management l MDR 2017 l SAP l Medical Devices l CDSCO Submission l EU MDR ll
- Role
- Lead Engineer at HCLTech
- Location
- Madurai, TN, IN
- LinkedIn followers
- 500 followers
About Manikumar T
Hi, I\'m a dedicated and results-driven professional with a strong passion for…
Experience
Lead Engineer
May 2025 — Present · Madurai, IN
Develop, implement, and maintain PMS plans in accordance with EU MDR, FDA, and other international regulatory requirements.*Collect and analyze post-market data including complaints, adverse events, customer feedback, service reports, and literature reviews.*Prepare Post-Market Surveillance Reports (PMSR) and Periodic Safety Update Reports (PSUR), as applicable.*Conduct trend analysis and signal detection to identify product performance issues or emerging risks.*Support vigilance reporting by assessing reportability of adverse events and coordinating timely submissions (e.g, MDRs, FSCA/FSNs).*Interface with notified bodies and regulatory agencies during audits and inspections related to PMS activities.*Collaborate with Clinical Affairs to integrate PMS data into Clinical Evaluation Reports (CERs).*Maintain PMS documentation and ensure timely updates in line with regulatory timelines.*Contribute to risk management processes by providing input based on real-world evidence and field data.*Support cross-functional teams in product improvement, corrective/preventive actions (CAPA), and product recalls if necessary.
Education
Anna University Chennai
Bachelor of Engineering - BE
2016 — 2020
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