Sethupathi S
Lead Engineer (Regulatory affairs)
- Role
- Lead Engineer at HCLTech
- Location
- Bengaluru, IN
- LinkedIn followers
- 500 followers
About Sethupathi S
Dedicative, resourceful, effective character in terms of quick learning, working, managing with proven as \"quality audit\" in a short period of time, being enthusiastic to achieve goal of an organisation as well as motto of mine
Experience
Lead Engineer
Mar 2021 — Present · Chennai, IN
Preparing Technical Documentation / Device Dossier for Invitro Diagnostic /Medical devices for the submission to notified bodies to attain CE mark certificate for the device.• Preparing Performance Evaluation Plan (PEP) to show the device is safe and effective as per the requirement by EU IVDR/MDR 2017 regulations.• Preparing Analytical performance report, Clinical performance report and scientific validity report for medical/Invitro diagnostic devices to prove the device is safe and effective as per EU MDR/IVDR 2017 regulations.• Having strong knowledge on Indian MDR 2017 Rules, and the relation between Indian MDR 2017 Rules and EU MDR/IVDR Rules.• Coordinating with clients to fulfil the project requirement and discussing regular project status/progress and timelines.
Education
Sri ragavendra Mt. higher secondary school
Hr. Sec
2010 — 2012
S.P.B HIGH SCHOOL
S.S.L.C
2009 — 2010
K.S.R College of technology
B.TECH
2012 — 2016
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