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Linu Thommi is listed as Director Regulatory Affairs || CTO || Medical Device Clinical Research at Meditix Solutions Private limited, based in Bengaluru, Karnataka, India. AeroLeads shows a work email signal at quintiles.com and a matched LinkedIn profile for Linu Thommi.
Linu Thommi previously worked as DIRECTOR-REGULATORY AFFAIRS CTO-CHIEF TECHNICAL OFFICER at Dr. Klinisch Research Pvt Ltd and Senior Technical Consultant at Meditix Solutions Private Limited. Linu Thommi holds Bachelor'S Degree, Biomedical/Medical Engineering from Sahrdaya College Of Engineering & Technology.
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14 years of experience in Product Management, Clinical Research, Usability, testing of medical devices in product development and testing environment. 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 functional Project Manager managing 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.
Listed skills include Biomedical Engineering, Medical Devices, Medical Imaging, Product Development, and 11 others.
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Bengaluru, Karnataka, India
Manages end to end clinical investigation studies, Post marketstudies, Clinical validation studies liaising with multiplestakeholders.
Bangalore Urban, Karnataka, India
Bangalore
Bengaluru Area, India
Kolkata Area, India
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Linu Thommi works for Meditix Solutions Private limited.
Linu Thommi is listed as Director Regulatory Affairs || CTO || Medical Device Clinical Research at Meditix Solutions Private limited.
AeroLeads has found 1 work email signal at @quintiles.com for Linu Thommi at Meditix Solutions Private limited.
Linu Thommi is based in Bengaluru, Karnataka, India while working with Meditix Solutions Private limited.
Linu Thommi has worked for Dr. Klinisch Research Pvt Ltd, Meditix Solutions Private Limited, Quintilesims, Quintiles, and Opto Circuits India Ltd.
You can use AeroLeads to view verified contact signals for Linu Thommi at Meditix Solutions Private limited, including work email, phone, and LinkedIn data when available.
Linu Thommi holds Bachelor'S Degree, Biomedical/Medical Engineering from Sahrdaya College Of Engineering & Technology.
Linu Thommi is listed with skills including Biomedical Engineering, Medical Devices, Medical Imaging, Product Development, Medical Device R&D, Healthcare, Clinical Research, and Cardiac Electrophysiology.
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