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:
QFI operates a fully documented EU Authorised Representative service designed to meet clients’ needs when placing a product on the European Market. The service is managed by Technical Specialists from Competent Authority and industry backgrounds with relevant adverse incident and compliance enforcement action skills.
A UK Responsible Person is an individual or a legal person established in the UK who acts on behalf of a manufacturer established outside the UK in relation to specified tasks regarding the manufacturer’s obligations under the relevant British laws, which may be sector specific. For instance, for medical devices this means the UK Medical Devices Regulations 2002 (as amended in 2019). A UK Responsible Person assures various legal obligations, duties and liabilities on behalf of a principal such as a medical device manufacturer.
This sector-specific standard helps manufacturers understand and ensure sustainable environmental realisation by considering recognised system boundaries, total medical device life-cycle, and environmental risk-thinking through a dedicated, stochastic management system. London, 10 August 2022 London-based medical
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
