Abhay Pangrekar, Medical Device Professional,BS ME (INDIA) MS IE (USA)
OVERVIEW: Medical device USA FDA compliant Devt. & Mfg. Ops.
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About me
Abhay Pangrekar, Founder-CEO of Good Cards Medical International, is an Engineering Professional, has 30+ yrs of hands on & management experience and involvement from device concepts, engineering development, A-Z manufacturing operations all the way to commercial shipments with Medical device industry in USA with Fortune 500 and Start-up companies.
Experience includes A)original Pulse Oximeter Monitors & Sensors manufacturing Eng. Mgmt. in SF Bay Area and co-mgmt. of sensors automation line. Additional experience with several medical instrumentation and catheters. Other key devices included B) design improvement & manufacturing of Women's healthcare catheter, C) involvement from concept all the way to total manufacturing Operations responsibility of a Cardiology beating heart internal imaging steering catheter for Atrial Fibrillation (AFIB), D) R & D design upgrade management of a Women's healthcare temperature Controller & Microwave Generator for AFIB E) Global supply chain management of Oncology Radiation equipment & Accelerated Sports Injury Recovery Devices and more.
Medical device development and manufacturing processrequires compliance with numerous regulatory requirements. My vision is to provide overview of medical device development and manufacturing operations process with regulatory compliance & FDA guidelines to young Entrepreneurs, engineering and medical students and several other interested beneficiaries world wide. This wonderful Medical Device industry is open to all educated personnel all over the world and its career is very very rewarding and gratifying.Every device you contribute to will improve somebody's life or even save somebody's life. I am hoping this overview will be very helpful to all the beneficiaries. Thank you very much and good luck.