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.

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.

OVERVIEW OF QFI SERVICES

SOLUTIONS FOR YOUR REGULATORY ISSUES

Would you like to extend your market and sell in EU or UK?

EU Authorised Representative Programme

EU AUTHORISED REPRESENTATIVE PROGRAMME

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.

UK RESPONSIBLE PERSON PROGRAMME

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.

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