Master the new MHRA draft regulations. Learn how the latest UK rules impact medical devices, SaMD, IVD compliance, and post-market surveillance.

Understanding the EUDAMED system, meeting the deadlines and getting your data right.

London, 9 August 2024 Haroon Atchia, CEO of London-based medical device consultancy Quality First International, is proud to announce the release of his new guidance on the application of the Hazard and Operability (HAZOP) technique within the medical device industry. This comprehensive guide aims to fill the existing knowledge gap in safety and reliability engineering for medical devices by providing in-depth analysis, practical insights, and grounded-theory research. The guidance, entitled “Hazard and Operability Study for Medical Device Manufacturing: Concepts and Application”, was originally conceived as part of Quality First International’s continuing professional development programme, and is designed for technical specialists, safety assessors, inspectors, and researchers involved in medical device safety and reliability engineering. It meticulously explores the HAZOP technique, a critical tool for identifying and managing operational hazards in industrial processes. Haroon Atchia leverages his extensive experience in inspecting, implementing, and optimising medical device industrial processes, including biomaterials, non-active and active surgical implants, clean room operations, and industrial sterilisation, to present a robust framework for HAZOP in medical device manufacturing. Key Features of the Book: 1. Comprehensive Introduction to HAZOP: The book begins with an explanation of the HAZOP study procedure, detailing the analysis phases and their relevance to the medical device lifecycle. It also includes historical context and practical examples through detailed worksheets. 2. Development and Application: The evolution of HAZOP technique is thoroughly examined, with Chapter 2 highlighting significant industrial accidents that underscore the importance of rigorous hazard analysis in the medical device industry. 3. Standards and Oversight: Chapter 3 analyses an existing HAZOP standard, discussing critical aspects such as safety oversight, post-study modifications, and the integration of HAZOP with medical device risk management systems and technical reports. Author's Vision: "My intention with this book is to provide a clear, contextual understanding of the HAZOP technique and to promote its technical application, particularly in the medical device industry where operational safety is paramount," said Haroon Atchia. "This book serves as a critical resource for professionals dedicated to ensuring the highest standards of safety and reliability in medical device manufacturing." About the Author: Haroon Atchia is the CEO of Quality First International, a leading medical device consultancy based in London. With decades of experience in the field, Atchia has established himself as an expert in medical device safety and reliability engineering. His work focuses on optimising industrial processes to enhance safety and compliance in medical device manufacturing. Availability: This 74-page document is available from QFI upon request, please contact enquiries@qualityfirstint.com. Price: 89.00 GBP . A discounted price ( 15% OFF ) is offered to QFI clients. About Quality First International (QFI) QFI is a London-based medical device consulting company specialising in solving its clients’ regulatory, technical and compliance challenges to enable medical devices to enter the global marketplace. QFI provides regulatory advice, quality assurance and clinical trial services, with particular emphasis on the European, US, Japanese, Australian, Canadian, Mexican and Chinese marketplaces. QFI’s clients range from start-up companies to multinational organisations, primarily developing a broad range of cutting edge, minimally invasive and cardiovascular products and implants. QFI also specialises in various remediation and business excellence initiatives including solutions to regulatory enforcement, corporate integrity arrangements and expert witness services. For further information please contact: Tel: +44 (0)208 221 2361, Email: enquiries@qualityfirstint.com

This sector-specific compilation of changes made to the UK regulations on medical devices creates a clear and thorough consolidated version of the Medical Devices Regulations 2002 London, 02 August 2024 London-based medical device regulatory consultancy Quality First International has published a unique consolidated version of the UK Medical Devices Regulations 2002, to present clearly all amendments made to the legislation to date, excluding changes applicable only in Northern Ireland. This document is suitable for manufacturers and regulatory experts in the medical device field who wish to understand the evolution of device regulation in the UK since publication of the original Regulations in 2002, up to and including the Medical Devices (Amendment) (Great Britain) Regulations 2023. The 437-page document is available from QFI upon request, please contact enquiries@qualityfirstint.com . Price: 450 GBP – a 15% discount is offered to QFI clients. About Quality First International (QFI) QFI is a London-based medical device consulting company specialising in solving its clients’ regulatory, technical and compliance challenges to enable medical devices to enter the global marketplace. QFI provides regulatory advice, quality assurance and clinical trial services, with particular emphasis on the European, US, Japanese, Australian, Canadian, Mexican and Chinese marketplaces. QFI’s clients range from start-up companies to multinational organisations, primarily developing a broad range of cutting edge, minimally invasive and cardiovascular products and implants. QFI also specialises in various remediation and business excellence initiatives including solutions to regulatory enforcement, corporate integrity arrangements and expert witness services. For further information please contact: Tel: +44 (0)208 221 2361, Email: enquiries@qualityfirstint.com .

This sector-specific standard has been designed to help manufacturers, developers and technical assessors design, develop and evaluate medical device apps