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.
QFI has developed over 100 training course, including customised training programmes to fulfil client needs and requirements. Courses are delivered by specialists possessing considerable first-hand experience in each topic, therefore, can respond to questions and real-life situations knowledgeably.
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:
The UKCA (UK Conformity Assessed) mark is a UK product marking used for certain goods, including medical devices, placed on the Great Britain market (England, Wales and Scotland) since 1 January 2021. The UKCA mark is not recognised in the EU, EEA or Northern Ireland and does not substitute for CE marking, so relevant products continue to require CE marking for sale in these markets.
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
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
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.
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.
