Ashutosh Mishra
Sr Manager Regulatory Affairs @Mindray India
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WORK HISTORY
Sr Manager Regulatory Affairs @Mindray India
EDUCATION
U P Technical University
M. Pharmacy, Pharmacy
UP Technical Board
B.Pharmacy, Science
ABOUT ASHUTOSH MISHRA
Application for Grant for manufacturing license & Loan License (MD-03, MD-04,MD-07 & MD-08) of Class A, B, C&D as per Medical Device Rules-2017 online Portal.Import license MD-14 of medical devices and component. Prepare technical file, Risk analysis report, Clinical evaluation report (MEDEV 2.7.2 Rev 04), Post market Surveillance (MEDEV 1.12/1 ), PMCF (MEDEV 2.12/2) Prepare Device Master File (DMF) & Essential Principles Checklist as per Medical Device Rules-2017. Prepare Site Master File as per Medical Device Rules-2017. Audit faced for the renewal of ISO-13485:2016 certification.Ensure to maintain Quality Management system as per standard/guidelines requirements, GDP, ISO 9001, ISO 13485;2016, FDA- QSR 21 CFR Part 820, European MDR, 21 CFR Part 803 (Medical Device reporting).For post-market changes, ensure impact assessment is identified in the affected country and change notifications are submitted accordingly with minimum impact on product supply.
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