LATEST NEWS

5 October 2020

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

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 … Continue reading “Quality First International updates post-Brexit UK Responsible Person Programme for medical device manufacturers”

Read More

31 January 2020

STANDARDS SEARCH PROGRAMME

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.

Read More

5 December 2019

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

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.

Read More

30 September 2019

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

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.

Read More

19 June 2019

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

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

Read More

11 February 2019

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

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 … Continue reading “Out now: A handy guide provides quick and simple insight into the world of medical device standards”

Read More