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 has implemented appropriate European Regulation and Directives, and the relevant authorities have authorised access to the European market.
Whether your business is a large blue-chip organisation, SME or start-up company, QFI can guide and assist with the many steps of obtaining CE Marking including:
QFI has significant experience in bringing a wide range of products to the European market, including:
Additionally, we can produce high-calibre usability and human factors engineering files and evidence, support user and post-market studies and evaluations, as part of structured surveillance programmes.
QFI also conducts detailed medical device risk analysis to exerting standards, complying with leading standards and practices, safety and reliability engineering and health service standards.
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Quality First International
1 Cook’s Road
Stratford
E15 2PW
London
United Kingdom
Tel: +44 (0)208 221 2361
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