PRODUCT · THE WORKFLOWS
One governed record. A workflow for each part of the file.
The live workflows draft from your own evidence, route what only you can answer, and end in an expert review and a sealed document. The rest is planned scope, and each page says so.
MDR Art. 10(9) · ISO 13485Live in the platform
Quality Management SystemThirteen Article 10(9) obligations, each backed by reviewed evidence from your own controlled documents, released as a sealed Evidence Appendix.See the workflowMDR Annex XIV · MEDDEV 2.7/1 Rev 4Live in the platform
Clinical Evaluation (CER / CEP)Clinical evaluation from plan to report: a sealed search protocol, a screened literature record, appraised sources, and a CER that cannot outrun its evidence.See the workflowISO 14971:2019In development
Risk ManagementThe ISO 14971 risk file as a governed workflow: hazards, controls and residual risk linked to the evidence that proves them.What is comingDesign verification & validationIn development
Verification & ValidationDesign V&V planning and reporting, linked to the risk controls and GSPR claims the results are meant to prove.What is comingMDR Art. 83–86 · PSUR · PMCFIn development
Post-Market SurveillanceThe living half of the file: PMS data intake, PSUR cadence and PMCF activity tracking on the same governed record.What is comingThe document map
Grouped by role, not sequence: pre-market and post-market artifacts do not form one ordered path. Selected applicability and delivery limits are called out on a chip; the final set is case-specific.
Core technical documentation
Device DescriptionDrafted todayGSPR ChecklistDrafted todayIFUDrafted todayLabelingDrafted today · not yet issuableEU Declaration of ConformityDrafted todayUDI / EUDAMEDDrafted todayQMS Evidence SummaryLive workflow
Clinical and risk evidence
CEPLive workflowCERLive workflowRisk Management PlanDrafted todayRisk Management FileManufacturer-maintainedV&V PlanDrafted todayV&V ReportDrafted todayTraceability MatrixIn development