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Dr. Akash Sharma

Expertise in EU Medical Device Regulation, ISO 13485 for Quality Management and ISO 14971 for Risk Management
Expertise in EU Medical Device Regulation, ISO 13485 for Quality Management and ISO 14971 for Risk Management

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, 10 books & participating in International conferences. Previously, he worked as the Regulatory Affairs Manager & Management Representative at KAULMED PRIVATE LIMITED. Currently, Dr. Sharma serves as the Head of Regulatory Affairs at Revital Healthcare (EPZ) Ltd. in Mombasa, Kenya. Read More...


Achievements

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Unveiling the Secrets of Good Manufacturing Practices
Books by Dr. Akash Sharma, Vriti Gamta, Gaurav Luthra

"Unveiling the Secrets of Good Manufacturing Practices: Building Excellence in Healthcare Manufacturing" is a comprehensive guide that unlocks the secrets to achieving manufacturing excellence through the implementation of Good Manufacturing Practices (GMP). This book provides valuable insights and practical strategies for navigating the complexities of GMP, ensuring product quality, regulatory compliance, and customer satisfaction. From facility design and do

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Vigilance Unleashed
Books by Dr. Akash Sharma, Vriti Gamta, Gaurav Luthra

Discover the world of pharmacovigilance, where patient safety takes center stage. In "Vigilance Unleashed: From Adverse Events to Patient Protection," we delve into the science and practices that safeguard patients from medication and medical devices' risks. Unravel the historical background, regulatory frameworks, and international collaborations that shape pharmacovigilance practices. From identifying adverse drug reactions to embracing emerging technologies

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Regulatory Compliance in the Healthcare Industry
Books by Dr. Akash Sharma, Ms. Vriti Gamta, Mr. Gaurav Luthra

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

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Risk-Based Quality Management in Healthcare Organization
Books by Dr. Akash Sharma, Ms. Vriti Gamta, Mr. Gaurav Luthra

"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, ensurin

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RISK MANAGEMENT FOR THE MEDICAL DEVICE INDUSTRY
Books by Dr. Akash Sharma, Ms. Vriti Gamta , Mr. Gaurav Luthra

"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 pr

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