qualityfirstinternational2910736c63960259ac01534fdca22fb3

Hazard and Operability Technique in Medical Device Manufacturing

Fri, 09 Aug 2024 12:36:01 GMT

Exploring the Hazard and Operability Technique in Medical Device Manufacturing: A New Guidance by Haroon Atchia

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

UK Medical Devices Regulations 2002

Fri, 02 Aug 2024 09:21:06 GMT

Consolidation of amendments to UK Medical Devices Regulations 2002 published by Quality First International

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)

For further information please contact:

Tel: +44 (0)208 221 2361, Email: enquiries@qualityfirstint.com .

Medical device standard QFIS 002:2022 on Medical Apps published by Quality First International

Wed, 29 Nov 2023 14:58:01 GMT

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

London, 29 November 2023

London-based medical device regulatory consultancy Quality First International has published Medical Device Standard QFIS 002:2022 Medical device apps - Technical specification - design, development and evaluation. This standard is intended for use as a general technical guide for medical device apps with the aim of ensuring applicable requirements are met by the medical app technology with respect to medical device function, safety and performance.

This standard is suitable for apps designed to be used by professions allied to medicine (e.g. biomedical engineering, chiropody, dietetics, medical physics, occupational therapy, orthoptics, orthotics, physiotherapy, prosthetics, psychology, radiography and speech therapy), in various practices (e.g. electroencephalography, electrocardiography, hearing aids and hearables, audiometry, surgical appliances, ultrasonics, nuclear medicine, industrial therapy and dental ancillary support) and, as necessary, by lay persons.

“This sector-specific standard on medical device apps was motivated by recognition of a void in published coherent technical criteria for medical device apps, presently manifesting in haphazard app design, utility and relevance when assigned a medical or allied use”, says Haroon Atchia, CEO and Technical Director of QFI. “This standard therefore specifies requirements for intended performance, design, design evaluation, manufacture and information supplied by the manufacturer, and tests to demonstrate compliance with applicable regulations.”

The standard is available from QFI upon request, please contact enquiries@qualityfirstint.com . Price: 69.00 GBP.

About Quality First International (QFI)

For further information please contact:

Tel: +44 (0)208 221 2361, Email: enquiries@qualityfirstint.com , Website: https://qualityfirstint.com .

New WEBINAR presented by Haroon Atchia is available

Thu, 16 Nov 2023 10:16:54 GMT

For medical device manufacturers who want to understand the requirements of the UK’s new MHRA MORE platform for submissions of device related incidents: New WEBINAR presented by Haroon Atchia is available

London, 16 November 2023

The London-based medical device consultancy Quality First International encourages all medical device manufacturers who want to understand the requirements of the UK’s new MORE platform for submissions of device related incidents to participate in their new webinar:

This webinar offers practical insight into the UK MHRA’s Manufacturer’s On-line Reporting Environment (MORE) platform . It will provide in-depth guidance on how to answer certain elements, covering all forms of incident and other reports which must be notified by manufacturers to the MHRA in the event of an alleged adverse incident involving a medical device. Special notification, for example originating at market surveillance, will also be covered.

Dedicated e-learning modules are presented on manufacturer’s incident reports, market interventions by manufacturers and other topics.

The course is intended for professionals involved in and/or performing adverse incident notification to the MHRA via the MORE platform, such as: Field assurance analysts, Complaint handling personnel, Market surveillance specialists, Enforcement officers, Compliance specialists, Responsible persons, Technical specialists, Regulatory affairs managers.

About Haroon Atchia (presenter of the webinar)

Founder of Quality First International Limited and Adveniunt Medical International Limited, formerly Senior Professional Technical and Scientific Officer at the Medical Devices Agency, UK Department of Health (UK MHRA), specialising in cardiovascular and implantable devices. Member of the Editorial Advisory Board for the Journal of Medical Device Regulation and formerly RAJ (Devices); Expert Witness, lecturer in medical device regulations at University of Cambridge (honorary).

WEBINAR DETAILS:

Date: 6 December 2023

Duration: 13:00 – 17:00 (GMT)

Further information: https://www.qualityfirstint.com/online-webinar

New medical device standard QFIS 003:2022 on an environmental (waste) management system specification just published by Quality First International

Thu, 02 Nov 2023 16:09:02 GMT

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)

For further information please contact:

Tel: +44 (0)208 221 2361, Email: enquiries@qualityfirstint.com , Website: https://qualityfirstint.com .

THE UK GOVERNMENT ANNOUNCES AN INDEFINITE EXTENSION TO THE RECOGNITION OF CE MARKING FOR CERTAIN BUSINESS SECTORS

Fri, 04 Aug 2023 16:00:19 GMT

Medical device and IVD companies are not affected by this extension

London, 3 August 2023

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 government states this is part of a “wider package of smarter regulations designed to ease business burdens and help grow the economy by cutting barriers and red tape. Following extensive engagement with industry, British firms will be able to continue the use of CE marking alongside UKCA”.

It is important to note, however, that the extension does not apply to medical devices or in vitro diagnostics (IVDs). The list of business sectors affected by the extension can be found in the official announcement:

https://www.gov.uk/government/news/uk-government-announces-extension-of-ce-mark-recognition-for-businesses

It is also important to understand that even though certain products may continue to use the CE mark, they must still comply with UK regulations.

Quality First International can assist manufacturers in becoming compliant with the UK regulations. Any enquiries or doubts about these latest developments and their possible consequences may be addressed to: enquiries@qualityfirstint.com .

About Quality First International (QFI)

For further information please contact:

Tel: +44 (0)208 221 2361, Email: enquiries@qualityfirstint.com , Website: qualityfirstint.com .

‘THE MEDICAL DEVICES (AMENDMENT) (GREAT BRITAIN) REGULATIONS 2023’ HAVE BEEN PUBLISHED – NEW TRANSITION DEADLINES AND RULES FOR MEDICAL DEVICES

Thu, 22 Jun 2023 21:42:06 GMT

The UK government has published Statutory Instrument No. 627 to amend the deadlines in the Medical Devices Regulations 2002 with effect from 30 June 2023.

London, 21 June 2023

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 new arrangements provide that certain CE marked medical devices may continue to be placed on the Great Britain market to the timelines that are applicable to their device class, with an end date of 30 June 2030.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published a useful infographic with all applicable timelines for both medical devices and in vitro diagnostics:

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1164062/Infographic_-_Devices_transition_timeline.pdf

Quality First International can assist medical device manufacturers in becoming compliant with the UK regulations. Any enquiries or doubts about these latest developments and their possible consequences may be addressed to: enquiries@qualityfirstint.com .

About Quality First International (QFI)

For further information please contact:

Tel: +44 (0)208 221 2361; Email: enquiries@qualityfirstint.com

AMENDMENT OF THE EUROPEAN MEDICAL DEVICE REGULATION (MDR) ENTERS IN FORCE – NEW TRANSITION DEADLINES AND RULES FOR LEGACY DEVICES AND CUSTOM-MADE DEVICES

Thu, 23 Mar 2023 21:25:58 GMT

London, 21 March 2023

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.

Regulation (EU) 2023/607 of 15 March 2023, amending Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices, came into force on 20 March 2023. The Regulation introduces an extension of the transition periods provided for in the MDR as long as certain conditions are fulfilled.

It also deletes, in both the MDR and the IVDR, the "sell-off" date, which is the end date after which devices that have already been placed on the market, and remain available for purchase, should be withdrawn.

The Regulation also introduces a new transition period until 26 May 2026 for manufacturers of Class III custom-made implantable devices to obtain certification of their Quality Management System by a Notified Body, as long as certain criteria are met.

“For manufacturers and Authorised Representatives with legacy devices that are eligible under Article 120(2) of the MDR, as amended, their certificates will either have been extended or reactivated automatically on 20 March 2023” explains Haroon Atchia, QFI’s CEO and Technical Director. “However, at this time, there is no mechanism to demonstrate that an expired certificate is still valid, so the Commission will need to provide formal direction and/or guidance on this issue in due course.”

The official press release from the European Commission can be found here:

https://health.ec.europa.eu/medical-devices-sector/new-regulations_en#extension-of-the-transition-periods-provided-for-in-the-regulations

Quality First International assists medical device manufacturers in becoming compliant with the MDR requirements. Any enquiries or doubts about the new Regulation and its possible consequences may be addressed to : enquiries@qualityfirstint.com .

About Quality First International (QFI)

QFI is a London-based medical devices 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. All submissions made by QFI have fulfilled the compliance requirements first time round, consistently. 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: www.qualityfirstint.com .

NEW BOOK RELEASE: “INTRODUCTION TO FUNDAMENTAL AND APPLIED QUALITY SYSTEM FOR MEDICAL DEVICES” JUST PUBLISHED BY QUALITY FIRST INTERNATIONAL

Thu, 26 Jan 2023 14:31:36 GMT

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)

For further information please contact:

Tel: +44 (0)208 221 2361, Email: enquiries@qualityfirstint.com , Website: https://qualityfirstint.com .

NEW ARTICLE: ONE YEAR LEFT TO COMPLY WITH UK MEDICAL DEVICES REGULATIONS

Fri, 13 May 2022 10:40:41 GMT

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 .

LEADERSHIP THROUGH ECO-FRIENDLY MEDICAL DEVICE MANUFACTURING AND WASTE MANAGEMENT: NEW REGULATORY SERVICE AVAILABLE FROM QFI

Wed, 09 Feb 2022 08:01:44 GMT

The London-based medical device regulatory consultancy Quality First International (QFI) has launched a new programme intended to assist medical device manufacturers in the development of environment-friendly, eco-designed and green medical devices.

“We think it is high time that sustainability and eco-friendliness become topics of discussion in the industry”, says QFI’s CEO and Technical Director Haroon Atchia. “State-of-the-art technology and a value-oriented business culture should go hand in hand nowadays. Our programme can assist value-driven medical device manufacturers to achieve environment-friendly medical devices and to gain leadership through continual improvement of business processes towards environmental sustainability. Our ideas and initiative are fundamental, visionary and innovative, not simply management system-based. Our goal is a certified environment-friendly medical device sector.”

About QFI’s Environmental Waste Management Programme

This new QFI programme unites global and sectoral legislation, initiatives, policies and standards in a seamless, integrated programme to assist manufacturers and other economic operators who design, manufacture, distribute and maintain medical devices in fulfilling environmental targets. QFI is adept in transforming environmental factors into effective, documented systems equipped to ensure clients produce optimally environment-friendly devices and services. With competence in requisite regulatory and technical areas, complemented by scientific professionals in medical device technology, QFI conducts environmental regulatory and management system impact assessments, formulates environmental risk policies, assesses risk thereof, and guides companies seeking improvements in environmental compliance.

About Quality First International (QFI)

For further information please contact:

Tel: +44 (0)208 221 2361, Email: enquiries@qualityfirstint.com , Website: https://qualityfirstint.com .

NEW MEDICAL DEVICE STANDARD QFIS 001:2021 ON SAFETY-RELATED FUNCTIONS AND ACTIVITIES

Wed, 09 Feb 2022 07:57:13 GMT

The sector-specific standard was developed to help manufacturers improve the function of medical devices and medical device systems with respect to safety and in accordance with well-established international norms.

London, 29 April 2021

London-based medical device regulatory consultancy Quality First International has published Medical Device Standard QFIS 001:2021 Medical devices – Functional safety – Product development at system level to help manufacturers achieve safer functionality of medical devices and medical device systems.

This standard is suitable for all device types and classifications with the pursuant aim of ensuring a high level of safety and protection in accordance with Council Directives 90/385/EEC, 93/42/EEC and 98/79/EC, Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR) and the UK Medical Devices Regulations 2020, SI No. 1478, as relevant. It is intended for use as a general guide in conjunction with relevant trusted standards and good practices.

“Safety is a fundamental qualitative and quantitative element in medical device development; however, this remains intangible for the industry in the absence of precise legislation or official standards defining functional safety requirements”, says Haroon Atchia, CEO and co-founder of QFI. “The activities described and recommended in the standard are intended to achieve improved safety of medical devices and are consistent with well-established international norms, so they should not present any additional burden to an organisation.”

The standard is available from QFI upon request, please contact enquiries@qualityfirstint.com . Price: 69.00 GBP.

About Quality First International (QFI)

For further information please contact:

Tel: +44 (0)208 221 2361, Email: enquiries@qualityfirstint.com , Website: https://qualityfirstint.com .

NEW GUIDANCE: UNDERSTAND HOW TO APPLY GENERAL PERSONAL DATA PROTECTION TO MEDICAL DEVICES TO AVOID NON-COMPLIANCE AND FINES

Wed, 09 Feb 2022 07:53:20 GMT

Quality First International has published a guidance book to raise awareness and preparedness of medical device manufacturers with regard to Regulation (EU) 2016/679, encompassing additional elements of the UK Data Protection Act 2018. This sector-specific guidance has been developed to help manufacturers understand and apply personal data protection obligations in the medical devices’ area.

London, 07 June 2021

London-based medical device regulatory consultancy Quality First International (QFI) has published a Medical Device Guidance Book: Guidance on application of Regulation (EU) 2016/679 on data protection to medical devices in the European Union and United Kingdom – Understanding and practice to help manufacturers achieve compliance with the pertinent regulations in the European Union and the United Kingdom.

“The guidance is motivated by recognition that the medical device sector is generally oblivious or cavalier about personal data protection and therefore might be ill-equipped to comply; or worse, exposed to enforcement that could otherwise be avoided easily ”, says Haroon Atchia, CEO and co-founder of QFI. “Fines can be huge for non-compliance with the regulations and this guidance can be used to apply the regulations to improve understanding and practice in the area of general personal data protection.”

The guidance book is available from QFI upon request, please contact enquiries@qualityfirstint.com . 178 pages, PDF, Price: 249 GBP .

About Quality First International (QFI)

For further information please contact:

Tel: +44 (0)208 221 2361, Email: enquiries@qualityfirstint.com , Website: https://qualityfirstint.com .

NEW ARTICLE: THE DESIGN PRINCIPLES OF ELECTRICAL SURGICAL INSTRUMENTS

Mon, 15 Nov 2021 10:42:41 GMT

Quality First International has published an article that examines the difficulties in analysing antecedent medical device technology used in modern medicine against new or evolving regulations.

London, 07 June 2021

London-based medical device regulatory consultancy Quality First International (QFI) has published an article: Electrical surgical instrument design principles to help manufacturers understand the importance of clear and categorical assessment of design principles in electrical surgical instruments by highlighting the general deficiencies of, and problems arising from, poor design considerations. The article then identifies factors to consider in the development of the optimum design for these instruments.

“Electrical surgical instruments were invented decades ago. Design principles were never elaborated, and very little thematic or phenomenological research is published on this subject”, says author Haroon Atchia, CEO and co-founder of QFI. “The article elaborates relevant medical device regulatory conformity assessment issues a specialist encounters when evaluating antecedent products, with a particular focus on electrical surgical instruments”.

The article is available from the QFI website for free download. 4 pages, PDF.

About Quality First International (QFI)

For further information please contact:

Tel: +44 (0)208 221 2361, Email: enquiries@qualityfirstint.com , Website: https://qualityfirstint.com .