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"Unlock the complexities of medical device regulation with 'Medical Device Regulatory Submissions.' This comprehensive guide demystifies the regulatory process, offering step-by-step instructions and expert insights to help you navigate submission preparation effortlessly. Whether you're a seasoned professional or new to the field, this book is your essential companion for ensuring compliance and getting your medical devices to market efficiently."
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MS. VRITI GAMTA, DR. AKASH SHARMA
Vriti Gamta is a acquiescent book author with a track record of seven published Books and seven Research Papers. She is an expert in Regulatory Affairs and Quality Management within the healthcare sector with a M.Pharmacy, specialized in Drug Regulatory Affairs. Vriti's areas of expertise include ensuring compliance with EU Medical Device Regulation, implementing ISO 13485 for Quality Management and adhering to ISO 14971 for Risk Management.
Dr. Akash Sharma is a highly experienced individual in the Medical Device Industry's Regulatory Affairs and Quality Management System. He holds a Ph.D. in Mechanical Engineering. He has authored several research papers, books and appeared at numerous international conferences. Compliance with the EU Medical Device Regulation, ISO 13485 for Quality Management and ISO 14971 for Risk Management are among Dr. Sharma's areas of competence.
