"It was a wonderful experience interacting with you and appreciate the way you have planned and executed the whole publication process within the agreed timelines.”
Subrat SaurabhAuthor of Kuch Woh Pal
"Risk Management for the Medical Device Industry: A Guide based on ISO 14971" is an essential resource for professionals in the fast-paced medical device industry. Authored by Dr. Akash Sharma, Ms. Vriti Gamta, and Mr. Gaurav Luthra, experts in regulatory affairs and quality management systems, this practical guide offers comprehensive insights into risk management and compliance. Covering the entire risk management lifecycle, it includes case studies, best practices, and practical examples, along with discussions on integrating risk management with quality management systems and emerging technologies. Equip yourself with the knowledge and tools to ensure safety and effectiveness in the global market.
Dr. Akash Sharma, Ms. Vriti Gamta , Mr. Gaurav Luthra
Dr. Akash Sharma is a highly accomplished professional in Regulatory Affairs and Quality Management System for the medical device industry. With a Ph.D. and M.Tech in Mechanical Engineering, he has focused his research on applying Risk Management Principles in the Medical Device Industry, publishing numerous papers and participating in international conferences.His expertise includes compliance with EU Medical Device Regulation, ISO 13485 for Quality Management, and ISO 14971 for risk management. As the Regulatory Affairs Manager and Management Representative at KAULMED PRIVATE LIMITED, Dr. Sharma ensures compliance with regulatory standards and drives quality initiatives.
Vriti Gamta is a budding book author and expert in Regulatory Affairs and Quality Management in the healthcare industry. With a Master's degree in Pharmacy specializing in Drug Regulatory Affairs, she has over four years of experience navigating complex regulations. Her expertise includes compliance with EU Medical Device Regulation, ISO 13485 for Quality Management, and ISO 14971 for risk management. As a Regulatory Affairs Executive at KAULMED PRIVATE LIMITED, Vriti ensures compliance and maintains high-quality standards.
Gaurav Luthra is an accomplished author and expert in the medical device industry with 17 years of experience as a Managing Director. He is currently leading as a Managing Director-KAULMED PRIVATE LIMITED. His extensive knowledge spans manufacturing, regulatory affairs, quality management systems, and research and development. Through his research and publications, Gaurav Luthra has established himself as a prominent figure in the field, contributing to technological advancements and promoting safe and effective medical devices.
