V5 Ultimate
Quality

Design controls

TL;DR

The FDA / ISO design-development discipline — planning, inputs, outputs, review, verification, validation, transfer, changes and the DHF.

21 CFR 820.30 (and ISO 13485 §7.3, EU MDR Annex II §6) requires that every Class II, Class III and select Class I device be developed under a controlled process: design and development plan, design inputs (user needs + regulatory + standards), design outputs (drawings, specs, code, labels), design review at defined milestones, design verification (do we meet the input?), design validation (does it meet user needs?), design transfer to production, design changes under change control, and a Design History File (DHF) that proves the design was developed per the plan.

The DHF is the lifelong evidence package an inspector asks for first.

Regulatory anchors
  • 21 CFR 820.30
  • ISO 13485 §7.3
  • EU MDR Annex II §6
How V5 handles it
Document control with hard kiosk-level training enforcement.
Versioned SOPs are only useful if operators are actually trained on the current version. V5 enforces it at the kiosk.
Related terms
Design verificationDHF21 CFR 820ISO 13485ISO 14971FDA QMSRBMReBMRMMRBPRBatch recordDHReDHRDMRCoACoCPIF21 CFR 21121 CFR 111Technical File
Want to see Design controls in V5?

Free trial, no credit card, onboard in days, not months.

Start freeBook a demo
Back to glossary