The UKCA (UK Conformity Assessed) mark is a UK product marking used for certain goods, including medical devices, placed on the Great Britain market 

QFI offers a wide and comprehensive range of audit and inspection services to the medical device sector operating a fully-documented process covering a wide

Quality First International performs regulatory compliance audits and inspections to levels expected and practised by Governmental organisations (notably the

CE marking is a declaration by the manufacturer that a product satisfies appropriate provisions of the relevant legislation in Europe. The CE marking demonstrates that a manufacturer 

CLASSify allows professionals in the medical device sector and other interested observers to classify products or interrogate the Class of a particular medical device. The website 

QFI assesses any existing Quality Management System (QMS) documentation for compliance with regulations and standarts and prepares a comprehensive 

Manufacturers often underestimate post-market surveillance requirements due largely to imprecisely defined legislation and guidelines, a situation further

The majority of device manufacturers must implement a Quality Management System to satisfy the country where they market their product. For example,

Manufacturers often underestimate post-market surveillance requirements due largely to imprecisely defined legislation and guidlines

The majority of device manufacturers most implement a Quality Management System to satisfy the countrywhere they market their product

When entering the US marketplace, a medical device manufacturer must subject his medical device to the general controls of the Federal Food Drug & Cosmetic