New article on the design principles of electrical surgical instruments

22 June 2021

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-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.

Electro surgical instrument

“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 here for free download. 4 pages.

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.

New Guidance: Understand how to apply general personal data protection to medical devices to avoid non-compliance and fines

9 June 2021

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-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 [email protected]. 178 pages, PDF, Price: 249 GBP.

New medical device standard QFIS 001:2021 on safety-related functions and activities just published by Quality First International

4 May 2021

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-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 (Amendment etc.) (EU Exit) 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 [email protected]. Price: 69.00 GBP.

Leadership through eco-friendly medical device manufacturing and waste management: new regulatory service available from QFI

1 March 2021

The London-based medical device regulatory consultancy Quality First International (QFI) launches 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 optimally 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.”

Medical device environmental waste management programme
Environmental waste management programme

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)

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.

 

The newly developed Environmental Similarity Index can help medical device companies gain insights into their waste management

29 January 2021

Haroon Atchia, CEO and co-founder of the London-based medical device regulatory consultancy Quality First International, has written a Technical Paper on medical device waste management introducing the notion of an Environmental Similarity Index (ESI). The use of the ESI is suggested to assist medical device manufacturers predict and assure development of environmentally friendly, eco-designed and green medical devices.

“We think it is time that sustainability and eco-friendliness become topics of discussion in the industry”, says Haroon Atchia. “This Similarity Index can assist the medical device industry to describe devices in simpler terms understandable by regulators and non-scientists alike. We also hope it helps all stakeholders to develop better environmental insight into medical devices and environmental waste management policies and controls.”

About QFI’s Environmental Waste Management System

This QFI service unites global and sectorial legislation, initiative, 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 environmentally 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.

The Paper can be downloaded from here.

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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.

Quality First International updates post-Brexit UK Responsible Person Programme for medical device manufacturers

5 October 2020

After a recent update of the UK MHRA’s guidance on “Regulating medical devices from 1 January 2021“, the British medical device regulatory consultancy Quality First International has updated its UK Responsible Person Programme, which offers UK representation services for medical device manufacturers that are located outside the United Kingdom and who want to place or continue to place their products with the CE mark of conformity on the UK market.

The UK Competent Authority, the MHRA, has advised that manufacturers not domiciled in the UK must appoint a formal UK Responsible Person (UKRP) to be able to continue placing medical devices on the UK market.

The UKRP will act on behalf of such a manufacturer to fulfil obligations of the latter under Regulation 7A (Amendment of Part II of the 2002 Regulations) in the draft version of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019.

With its UKRP programme, QFI offers the following services:

  • registration of medical devices with the MHRA
  • examination of conformity of products to standards required by the MHRA
  • notification of adverse incidents and other notifiable situations to the MHRA
  • serving as a legal entity and point of contact pursuant with the applicable UK Medical Devices Regulations 2002
  • ensuring permanent availability of technical documentation to the MHRA pursuant to the UK Medical Devices Regulations 2002

Medical device manufacturers interested in this service may contact QFI by email [email protected].

STANDARDS SEARCH PROGRAMME

31 January 2020

QFI offers a unique Standards update and review service for medical devices through our Standards Search Programme that ensures rigorous and accurate conformity to Standards is achievable.

QFI offers a unique Standards update and review service for medical devices through our Standards Search Programme that ensures rigorous and accurate conformity to Standards is achievable.

Different service levels are offered as discrete packages depending on the depth and breadth each standard is applied by a Manufacturer, allowing concentration of effort where it is required.

Among the services offered are:

  • Detailed Standard Applicability Report analysing (clause-by-clause application, where necessary) compliance or Conformity which recognises Consensus Standard Requirements/Article 51. Council Directives 93/42/EEC; 90/385/EEC; 98/79/EC (as relevant) (for the latter, Common Technical Specifications), CMDCAS, TGA or other schemes as appropriate
  • List of Standards / Special Controls with headline changes
  • Applicable Standards Update List

The Standards Search Programme consists of an annual Standards Search membership fee per product/homologous product group or generic product group covering the following:

  • Review of Standards Search form listing Standards applied or application desired, submitted by the client
  • Initial examination and review of technical documents submitted supporting application of Standards
  • Registration of technical documents in the database
  • Correlation of Standards expected to be known to the Manufacturer for each product group
  • Detailed Standards Applicability Report

First basic environmental performance requirements for medical devices defined by Quality First International

5 December 2019

Quality First International (QFI) has published an article in the November 2019 issue of the Journal of Medical Device Regulation which outlines the very first Basic Environmental Performance Requirements (BEPR) for medical devices.

An article published by London-based medical device regulatory consultancy Quality First International conceives the first environmentally-related requirements for medical devices as it is time that sustainability and eco-friendliness become topics of discussion in the industry.

Quality First International (QFI) has published an article in the November 2019 issue of the Journal of Medical Device Regulation which outlines the very first Basic Environmental Performance Requirements (BEPR) for medical devices.

“The environmental impact of medical devices, their contribution to pollution, plus their sustainability, receive no attention,” says the author Haroon Atchia, CEO and Chief Technical Officer at QFI. “However, they should be considered hugely significant factors considering the quantities of medical devices used globally.”

Protect the environment

The article proposes a number of Basic Environmental Performance Requirements (BEPR) to define attributes that sustainable medical devices should achieve in order to promote good medical device environmental quality through fundamental design and construction to ensure high-performing, environmentally-healthy products with the lowest possible environmental waste potential.
“It is hoped that these BEPR will inspire improved medical device design to establish medical device environmental, green and sustainability state-of-the-art concepts”, confirms Atchia.

The article may be ordered from the Global Regulatory Press website – GlobalRegulatoryPress.com – or by email to [email protected] Price: £50 (plus VAT as applicable). Reference: “Basic Environmental Performance Requirements for medical devices: Attributes for eco-friendly, green and sustainable medical devices (November 2019)”.

For further information please contact:
Tel: +44 (0)208 221 2361 | Email: [email protected]

Do medical devices used in psychology receive the attention they deserve?

30 September 2019

QFI launched the first specially-devised and dedicated Brexit medical device support service, to prepare manufacturer’s and other medical device economic operations for Exit day, thereby avoiding disruption to marketing in the United Kingdom as well as the remaining EU Member States.

An article published by London-based medical device regulatory consultancy Quality First International explores whether the design, regulation and evidence-base of medical devices used in cognitive psychology is sufficiently accommodated and specified to permit achievement of clinical effectiveness.

The London-based medical device regulatory consultancy Quality First International has published a research paper on the use of medical devices to treat mental disorders.

Mental health is a global health concern, with the number of people being affected by mental illnesses increasing and therefore positioning mental disorders as one of the leading causes of illness and disability worldwide. Less known to a wider public, medical devices are not only used for physical illness, they are also used in the field of psychology and hence can be used to diagnose and treat mental illnesses.

Medical devices used in psychology include neuroimaging machines, which can be used to help diagnose conditions like depression and epilepsy, or apparatus used to treat mental illnesses such as brain stimulation devices like electroconvulsive shock or even nerve stimulation devices. Using these devices is becoming an increasingly more popular form of treatment, therefore it is important that there are effective regulations and design processes in place to ensure safety and conformity, as there are various ‘off-label’ types.

It is also crucial that there is an understanding of the effect devices may have on psychological wellbeing, which has not previously been included as a regulation that manufacturers must follow. A device can add extra stress or anxiety, which has been discovered to prevent people recovering.

“A large challenge encountered during the research was that there was little information on the regulation of devices used in psychology, which at first was a problem but then became a revelation and precipitated a proposal that this gap should be filled”, states Eleanor Brown, the author of the article and Research Student at QFI.

The research paper explores if the design, regulation and evidence-base of medical devices used in cognitive psychology is sufficiently-accommodated and specified to permit achievement of performance (clinical effectiveness), taking into account human factors, psychological impact, transcranial magnetic stimulation, electroconvulsive therapy, nerve stimulation, dermal response and mental models.

The article may be ordered direct from QFI: [email protected], Price: £49 (plus VAT as applicable), reference: “Review of the design, efficacy and regulation of medical devices used in psychology, The psychological impact of medical devices and how psychology is incorporated in the design of medical devices” | Quality First International.

QFI offers assistance to medical device companies affected by LRQA’s cessation of Notified Body services under the Medical Devices Directives

19 June 2019

London-based medical device regulatory consultancy Quality First

London-based medical device regulatory consultancy Quality First International offers medical device manufacturers support on this matter, including transitions to another Notified Body.

The British medical device regulatory consultancy Quality First International advises several client companies affected by the imminent cessation of LRQA’s services as a Notified Body under the current Medical Devices Directives.

QFI has a team in place to help any company requiring support on this matter, including transfers and transitions to another Notified Body for the Medical Devices Directive (93/42/EEC) and the In-Vitro Diagnostic Directive (98/79/EC), facilitating transfer, aligning CE technical documentation expectations to minimise any risk of disruption to business, and agreeing expedition.

Affected medical device companies were informed by LRQA that any current CE certificates will be withdrawn 90 days from the official date of cessation of LRQA’s services.

Medical device manufacturers interested in this service may contact QFI by email [email protected] or telephone +44 (0)208 221 2361.