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.”

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 sales@globalregulatorypress.com. 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: enquiries@qualityfirstint.com

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: enquiries@qualityfirstint.com, 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 enquiries@qualityfirstint.com or telephone +44 (0)208 221 2361.

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

19 February 2019

London-based medical device regulatory consultancy Quality First International now offers post-Brexit UK representation services that will become mandatory for medical device manufacturers located outside the UK.

The British medical device regulatory consultancy Quality First International has launched 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 after the UK’s exit from the European Union on 29 March 2019.

The UK Competent Authority, the MHRA, has advised that once the United Kingdom exits the European Union – with or without an agreement being reached between the two parties – 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 enquiries@qualityfirstint.com or telephone +44 (0)208 221 2361.

Out now: A handy guide provides quick and simple insight into the world of medical device standards

11 February 2019

London-based medical device regulatory consultancy Quality First International has written a basic guide to the use of standards to demonstrate fulfilment of product specification, conformity with European regulations or specified requirements of medical devices.

Haroon Atchia, CEO and co-founder of the London-based medical device regulatory consultancy Quality First International, has written a basic guide that helps medical device manufacturers to establish the status of technical standards used in the medical device industry and how they may be applied, how to evaluate a standard and – perhaps most importantly – how to provide evidence necessary to demonstrate conformity and limits conferred.

Taken from introductory and intensive training courses developed by Quality First International, and systems, procedures and activities created and implemented for numerous client medical device manufacturers, it is hoped this basic guide can provide readers with quick and simple insight into the world of technical standards used in the medical device industry.

“The guide is presented in a question and answer format to reflect the types of questions commonly asked by medical device manufacturers during our training courses”, states Haroon Atchia. “In addition there are a few Q&As that are not immediately obvious to allow introduction and quick access to the subject.”

The guide has been published by Global Regulatory Press and may be purchased directly from their Bookstore, price: £65 (plus VAT as applicable).