QNET Offers affordable assistance through its EU Entry Package QNET's 'Doing it Once' methodology is for device manufacturers of Risk Class: 1+ measuring function or sterilization, IIA, IIB, III. Clients interface directly with a QNET medical device expert, including European Certified lead assessors and certification managers, USA-FDA consultants, design and manufacturing engineers with extensive experience in the medical device industry, earned at EU Hospitals, Notified Bodies, US and EU manufacturers and laboratories. 'Doing it Once' eliminates duplication of effort. QNET's consultant starts with a review of the device compliance intelligence already in existence in a USA FDA 510(k), for application in building of CE technical file in accordance with Medical Device Directive. Once the existing device compliance intelligence has been entered into the CE technical file, the consultant assists with its completion through our existing: TECHNICAL FILE - EU ENTRY PACKAGE The seven steps delivered by E-Mail are: STEP 1 - Organizing the devices into product categories and groups for each technical file and completing a checklist of suppliers and sub-contractors. STEP 2 - Completing a checklist of existing documentation by product. STEP 3 - Completing a checklist of existing GMP/FDA - ISO 9000/ISO 13485 documentation, including procedures. STEP 4 - Identifying, documenting and arranging for the performance of required tests. STEP 5 - Audit for gaps between existing documentation and the documentation specified in the customized QNET documentation matrix prepared in accordance with the Medical Device Directive. STEP 6 - Produce missing documents for Risk Analysis and Checklist for Essential Requirements, using examples provided as part of the EU Entry Package. STEP 7 - Produce missing documents identified in Step 5 using some of the examples provided as part of the EU Entry Package, including the 'Declaration of Conformity". In each Step the manufacturer will receive: Instructions Clarifications Forms If required - On-site visit Deliverable: Technical file with the required documentation and the extra benefit of the 'Doing it Once' system guaranteeing consistent use of a company's compliance intelligence applied to EU and USA applications and elimination of duplicate effort. For companies not yet certified to ISO 13485, click HERE for additional information.

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