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Ashokkumar ThakkarHead – Clinical Research & Medical Writing at Meril Life Sciences Pvt. Ltd.
Authentic, a results-driven business leader with 15+ years experience in clinical strategies, trial design and expedited execution for Class II / III medical device therapies. Specialized ten of those years in early-stage first-in-human and pre-market trials for medical device start-ups. Excels in creating and motivating high performing cross-functional teams through servant leadership to achieve accelerated clinical trial execution to align with corporate objectives—100+ publications in peer-reviewed journals.
Prepare regulatory documents and responses to regulatory authorities, specifically working on Clinical Evaluation Reports (CERs)
Combine an understanding of scientific and research methodology, medical device regulations and guidelines, and product knowledge, to support Regulatory Affairs submissions for CE Marking of new devices and maintaining CE Mark for existing devices per MEDDEV 2.7/1 Rev 4, MDD, AIMDD, and EU MDR 2017/745.
An experienced researcher with a demonstrated history of working in the medical device industry. Medical device experience includes vascular stents, scaffold, Heart Valve, knee replacement, hip replacement, IUDs, Coronary Ballons, stapler, suture, Blood Glucometer etc.
I am skilled in Clinical Evaluation Reports (CER), SSEDs, Clinical Study Reports, Regulatory and Medical Compliance, MDR, MEDDEV 2.7/1 Revision 4 (and associated EU directives, regulations, and guidelines), ISO, Good Laboratory Practice (GLP), Medical Devices, Laboratory Medicine.