The vital role played by Hospital Sterile Services Departments in the success of operations has been recognised by the European Community who have taken steps to assure the level of service provided. This has resulted in the Medical Devices Directive, which has been fully in force since June 1998.

In a nutshell the main requirements of this are

• Operating to a Quality Management System such as ISO9000.

• Justifying all the processes used to produce a sterile product.

• Produce a signed declaration that the products comply with the directive

Of course achieving these requirements is no easy task even for a department that may already be complying. For example the 'Essential Requirements' section of the Medical Devices Directive contains in excess of 80 paragraphs and sub paragraphs that products need evaluating against. How each type of product conforms to each of these paragraphs must be documented as part of a Technical File, including the back up evidence.

By using Optimum Systems for Quality you will benefit from a consultant who has a real understanding of the Medical Devices Directive so the system introduced will suit your exact needs at that point in time, it will not be a 'bolt on' system. Six clients have been successfully taken through CE Marking using the same practical, common sense approach as that used to take over 50 clients through ISO 9001 and ISO 9002.

Assessment authorities who have assessed these clients for compliance with the Medical Devices Directive include BSI, SGS Yarsley, NQA, Amtac.