The DevDx document library is unique. We have developed a full suite of documents enabling an “out of the box” experience for you to establish your own ISO 13485:2016, 21 CFR 820 and MDR (2017/745)/IVDR (2017/746) compliant QMS.
All of our documents have been written to cover EU, US and AU. The documents are fully populated and editable (not templates), cross-reference each other and applicable regulations and clauses of the standards. If you are happy to accept our document identifiers then you shall only need to customise to work flows, roles and responsibilities. The first Standard Operating Procedure - Writing an SOP - is free so that you can see our format.
Navigating the document library is easy via the search bar, for a document type or name. When you select a specific document you shall be able to view the clauses of the various standards that you shall comply with by using this document and the contents of the first page.
Please visit our library regularly as we complete and update our documents.
Of course if you need help with implementation of your QMS, a gap analysis against the new US QMSR or are looking at a software solution, please contact us.
