"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-Based Quality Management in Healthcare Organization: A Guide based on ISO 13485 and EU MDR" is a comprehensive handbook that offers practical guidance for healthcare professionals to excel in risk-based quality management. It explores the regulatory landscape of the healthcare industry, emphasizing ISO 13485 and EU MDR as the foundation. The book provides a step-by-step approach to implementing effective risk assessment and mitigation strategies, ensuring compliance with international standards. It includes best practices to navigate risk management throughout the medical device lifecycle. The guide also addresses integrating risk management into existing quality management systems, conducting audits, and meeting EU MDR requirements. By mastering the principles in this guide, professionals can enhance patient safety, improve product quality, and achieve regulatory compliance. It is a valuable resource for healthcare professionals involved in device design, manufacturing, testing, and regulatory affairs.
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 (KAUL-Medizintechnik GmbH), 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 (KAUL-Medizintechnik GmbH), 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 (KAUL-Medizintechnik GmbH). 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.
