QW Medical LLP
ISO 13485 2003
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
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
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.
Order your copy today!