Technical file and documents
Follow document work, answer gaps, control source files and understand delivery.
8 guides
Read the technical-file trackerUnderstand every document row created for an MDR or IVDR case.Understand document statusesDistinguish drafting, review, issued and delivered states.Read a document once it is deliveredKnow when a document becomes readable in your case, and what the placeholder says until then.Answer document gapsUse the four client buckets and the action each gap actually exposes.Declare and control source documentsClassify manufacturer documents, record their status and preserve supersession history.Use the organisation document libraryFind uploaded manufacturer sources without confusing them with case outputs.Download a released deliverableUnderstand what the case makes available and why a previous release can be withheld.Verification and validation of your deviceWhat the two V&V rows on your tracker mean, the one question you answer, and the test reports you provide.