Regulated & Industry Verticals
Device R&D
Design controls, risk files, DHF/DHR, and UDI.
QMSR / ISO 13485 design controls, risk management with computed residual-risk acceptability, design history and device master records, regulatory pathway, UDI, EU MDR / EUDAMED, and post-market surveillance.
What's inside
10 capabilities in Device R&D — every one a real surface in the product, not a roadmap item.
- Overview
- Design Controls
- Risk Management
- Regulatory Pathway
- Post-Market Surveillance
- UDI
- EU MDR / EUDAMED
- DMR
- DHR
- DHF
See it in action
Not a dashboard tour — the actual working screens in Device R&D, on live demo data.
Who it's for
Medical-device makers who need engines, not CRUD shells.
Connected to
Same database, same records — Regulated & Industry Verticals works as one.
Food & BeverageFSMA 204 traceability and food-safety plans.CosmeticsMoCRA end to end — registration to adverse events.Pharma & BiologicsCompound registry, IND programs, and PPQ.Life SciencesPortfolio, pipeline, and requirements tracing.Regulatory AffairsSubmissions, commitments, and HA meetings.Clinical TrialsStudies, EDC, eTMF, IRT, and eConsent.PharmacovigilanceICSRs, signals, aggregate reports, and MDR.R&DELN, LIMS, biobank, and assays.NonprofitDonors, grants, funds, and Form 990 prep.
See Device R&D on your own data.
Book a demo