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, Website: https://qualityfirstint.com.

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

This sector-specific standard helps manufacturers understand and ensure sustainable environmental realisation by considering recognised system boundaries, total medical device life-cycle, and environmental risk-thinking through a dedicated, stochastic management system. London, 1 August 2022 London-based medical device regulatory consultancy Quality First International has published medical device standard QFIS 003:2022 Medical device environmental (waste) management system specification . It is intended for use as a sector-specific management system and to be used in conjunction with relevant trusted standards and good practices. The standard is applicable to all types of medical devices, support services, externally-provided raw materials, intermediate products and components, constituents, processes and utilities applied to produce, supply, sustain and ultimately dispose of medical devices. “Sustainability may not be achieved without both full characterisation of a medical device to its environmental fundamentals and its imprint throughout its complete life-cycle, says Haroon Atchia, CEO and Technical Director of QFI. This is crucial in all environmental compartments relevant to a medical device, defining its planetary or system boundaries and safe operating space, intertwined with its basic environmental performance and impact. Standard QFIS 003:2022 is the first and only standard on this specific subject matter to date. Atchia further explains that “only QFI can assist medical device manufacturers with the know-how and practical resources to implement concepts and radical solutions described by our standard. Also, only QFI’s environmental technical specialist team can conduct comprehensive assessments to the standard. We offer these services as part of our business programme to our members but can also do so on an individual project basis.” The standard is available from QFI upon request, please contact enquiries@qualityfirstint.com . Price: 175.00 GBP. The price for QFI Medical Device Environmental Management Programme members is 139.00 GBP. 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 , Website: https://qualityfirstint.com .

The Department for Business and Trade (DBT) has announced its intention to indefinitely extend the recognition of CE marking for certain industry sectors. This decision means that UKCA marking will no longer be mandatory from the end of December 2024 for businesses included in the 18 regulations that fall under the Department for Business and Trade (DBT).

The Medical Devices Regulations 2002 currently specify that the acceptance of CE marked medical devices on the Great Britain market will end on 30 June 2023. However, on 9 June 2023, the UK government put in place legislation to extend the acceptance of certain CE marked medical devices on the Great Britain market in response to similar changes made in the European Union.

The European Commission has published an amendment to the Medical Device Regulation (MDR) in the Official Journal. One of the amendment’s main features is the extension of the MDR transition periods until 31 December 2027 or 31 December 2028, depending on the device class.

London, 21 December 2022 London-based medical device regulatory consultancy Quality First International has published a new book entitled Introduction to fundamental and applied quality system for medical devices . This book aims to identify the fundamentals of a quality system and provide a science-based construct that will hopefully produce a greater understanding and application of quality system standards. “Despite numerous publications about quality, quality systems and quality management systems, the respective meanings of these terms are less clear than one might perhaps initially think.”, says Haroon Atchia, author of the book and CEO and Technical Director of QFI. “Even the meaning of system promulgated by ISO is unclear and certainly incomplete. There is no legal definition of quality in the context of a consumer product, including a medical device, contrary to popular myth and extensive use of the word throughout medical device regulations and related texts. Contemporary medical device manufacture and service organisations therefore routinely misinterpret quality as a documented management system, somehow losing sight of true definitions.” The ubiquity and importance of the use of quality systems and quality management system standards obligates the need for an improved definition of quality as a metric along with a clarification of why each quality system element is an essential or characteristic component of a quality system. The book is available from QFI upon request, please contact enquiries@qualityfirstint.com . Price: 130.00 GBP . 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 , Website: https://qualityfirstint.com .

London-based medical device regulatory consultancy Quality First International (QFI) reminds medical device manufacturers of the approaching end of the grace period for transitioning from compliance under the European Directives and Regulations for medical devices and IVDs London, 11 May 2022 With the end of the transition period set for 30 June 2023, QFI encourages all manufacturers to apply to UK Approved Bodies as soon as possible to avoid discontinuation or failure to place products on the Great Britain market. The Enforcement Agency (MHRA) will no longer accept medical device compliance under Council Directives 93/42/EEC, 90/385/EEC and 98/79/EC, nor Regulations (EU) 2017/745 / 2017/746 after 30 June 2023. Further, all manufacturers intending to place medical devices on the UK market must comply with the Medical Devices Regulations 2002 No. 618 (as amended) and apply a UKCA mark to their products. “The new requirements apply to devices of all classes. We anticipate long conformity assessment processes with UK Approved Bodies”, says Haroon Atchia, CEO and Technical Director at QFI. “Furthermore, the UK MHRA will only accept registration of devices from manufacturers where the manufacturer is based in the UK. If the manufacturer is based outside the UK, he must appoint a UK Responsible Person.” 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. The company also acts as a UK Responsible Person for manufacturers located outside of the UK. 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 , Website: https://qualityfirstint.com .