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.
The US Food and Drug Administration (FDA) requires that any manufacturer without a place of business in the USA to establish and appoint the registration with the FDA, a United States Agent.
QFI has a fully operational office in the USA, allowing to act as US Agent for device manufacturers and defend the manufacturer’s interests at all times.
With the end of the transition period set for 30 June 2023, QFI encourages all manufacturers to apply to UK approved bodies as soon as possible to avoid discontinuation or failure to place products on
Quality First International has published an article that examines the difficulties in analysing antecedent medical device technology used in modern medicine against new or evolving regulations. London-based medical device regulatory consultancy Quality First International (QFI)
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
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
