CE Files
Whilst working with partners and clients in the development of product procedures, documentation and CE files can be prepared for most medical devices.

The development of a CE File is an extremely important procedure as it contains the information required to show that the product properly complies with the requirements of the directives to which it applies.

Minimal CE file requirements will include the following:




ISO 9001:2008 Certificate
ISO 13485:2012 Certificate
Focus Product Developments Ltd
Brian Royd Mills, Saddleworth Road, Greetland, Halifax, West Yorkshire, UK, HX4 8NF
Tel: +44 (0) 1422 375723 / Fax: +44 (0) 1422 376064 / Email: sales@focuspd.com
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