Regulatory Compliance in the Healthcare Industry: Navigating the Complexities" is a comprehensive guide that equips healthcare professionals with the knowledge and strategies needed to ensure compliance with regulatory requirements. Authored by experts in healthcare compliance, this book covers key topics such as patient privacy, data security, quality of care and compliance program development. Real-world case studies, best practices and practical tools make this book an essential resource for healthcare professionals, compliance officers and administrators seeking to navigate the intricate landscape of regulatory compliance and promote ethical practices in the ever-evolving healthcare industry.
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Dr. Akash Sharma, Ms. Vriti Gamta, Mr. Gaurav Luthra
Dr. Akash Sharma is a highly skillful 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, books 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 talented book author having two books and seven papers published in the industry. She is an 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 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.
