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].

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

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

Feb19

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