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ISO 13485

Documentation System

QW Medical LLP    


ISO 13485 2003    

Revision 01     

This ISO 13485 documentation set contains an ISO 13485 / ISO 9001 Quality Manual and approximately 70 procedures and forms. It will save you enormous time in developing a Quality Management System compliant with ISO 13485 2003 standard. Our extensive documentation template set has helped hundreds of companies to establish effective quality management systems quickly and easily. The templates are in the MS Word and MS Excel formats and are easy to modify to address your specific needs. This documentation set will help you define a solid system for compliance with ISO 13485 2003, FDA 21 CFR 820, Canadian MDR and European Medical Device Directive.

Do not forget to download a free copy of ISO 9001:2000-ISO 13485:2003-21 CFR 820 Correspondence Matrix! which we offer with a permission of the author. Please be patient - it is a relatively large pdf file.  

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