Welcome to Quality First International
leading global medical devices consultancy
With extensive insight and business know-how in the global medical devices regulatory field, QFI’s consulting services are designed to assist you at any stage of your business with everything from product design, clinical evaluation, including clinical development and investigation design, research and monitoring to market entry, distributor search, sourcing, and market research to regulatory strategy and compliance, product registration, authorised representation, importer service, plus all requirements of market surveillance and quality compliance all over the world.
Our technical expertise, specialist knowledge accuracy and confidentiality can help you to accelerate market entry, reinforce approval of your medical device and resolve compliance issues or challenges encountered during regulatory approval processes, including enforcement case and litigation.
OVERVIEW OF QFI SERVICES
Solutions for Your Regulatory Issues
QFI has critical insight, expertise, business knowledge and experience with all types of medical devices and certain other regulatory-related disciplines. This is reflected in the scope of our core services, including:
- 1Medical Device regulatory support and standards compliance
- 2International Representative Programme
- 3Biological Safety Programme
- 4Quality Management Systems, audits and inspections
- 5Microbiology Advisory Program
- 6Medical device registration
- 7EU Authorised Representation
- 8Clinical Trials Program
- 9UK Responsible Person service
- 10Official Importer service
- 11Medical device environmental waste management & sustainability
- 12EU Authorised Data Protection Representative Programme (EUDPRP)
- 13StandardSearch Programme
- 14Medical device market surveillance
5 October 2020Quality 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”
5 December 2019First 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.
30 September 2019Do 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.
19 June 2019QFI 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”
11 February 2019Out 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”