--- name: Medical device and IVD teams shortName: Device & IVD teams category: Specialist evidence teams stage: next stageLabel: Design-partner horizon navDescription: Shape traceable, living device-evidence workflows. description: Explore planned source-grounded CER, PMCF, and IVD evidence workflows and the design-partner path available today. related: - cros - heor-market-access-teams - pharma-biotech-teams --- # Update literature narratives without starting over. Tie new evidence to the claims and decisions it changes. ## Outcome ### Faster evidence updates See what changed, what it affects, and what needs review. #### Reuse decisions Carry accepted rationale forward. #### Trace each update Connect new sources to affected claims. #### Defend the version Keep the review trail inspectable. ## The current workflow ### Every evidence update creates document work. #### Search history is part of the defense Show what was searched, selected, excluded, and changed. #### One evidence base feeds many outputs Device and IVD documents reuse evidence in different ways. #### Updates need controlled state New sources must reveal what needs review. ## How it works ### Design the evidence system before the draft. #### Map the linked suite Define shared searches, evidence, claims, and documents. #### Preserve provenance Capture search, screening, and exclusion decisions. #### Review the change Show each change, its impact, and required approval. ## Why 7Scholar ### Credible device support needs more than prose. > A living source-to-claim trail for recurring evidence updates. #### Reproducible search history Retain search, screening, exclusion, and full-text decisions. #### Living evidence state Carry rationale forward and surface new-source impact. #### Regulated structures Give each document its own sources, checks, and exports. ## Where 7Scholar fits ### What works today—and what comes next. Device and IVD workflows are a design-partner direction, not a validated product claim. #### Available now **Ready to explore** - Design-partner workflow mapping - General evidence organization - Narrative-review manuscript projects #### On the horizon **Sequenced expansion** - Linked CER and PMCF workflows - IVD performance-evaluation suites ## Questions ### Is there a compliant CER workflow today? Not yet. It requires search provenance, living-document state, review exports, and validation. ### What does a design partnership involve? Bring an evidence package to map sources, update logic, review gates, and defense artifacts. ### Will 7Scholar replace our QMS? No. Quality, approval, validation, and regulatory duties stay in governed systems.