Resources

RESOURCES AND INTELLIGENCE

FOR MEDICAL DEVICE REGULATORY PROFESSIONALS

QFI offers a wide range of articles, discussion papers, guidance, contributions and other resources on international medical device regulation, including EU Regulation, US Regulation, Standards, Quality, Microbiology and many more.

To order any of these publications, please send an email to [email protected].

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

Jun09

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

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

May04

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

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

Mar01

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

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

Jan29

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

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

Oct05

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

STANDARDS SEARCH PROGRAMME

Jan31

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

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

Dec05

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.

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

Sep30

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

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

Jun19

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

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

Feb11

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