QMSR · ISO 13485:2016 · ISO 14971 · MDR/UKCA
Device quality records for FDA QMSR, ISO 13485 and CE/UKCA routes.
Keep device records, CAPA and complaints connected.
Device Records Connected
Production records, CAPA and complaints linked to the lot.
Current Regulation
Written for FDA QMSR (Part 820, effective 2 Feb 2026) and ISO 13485.
People decide
Release and reportability stay decisions for your quality team.
What goes wrong today3 common problems
QMSR harmonization is a documentation project nobody scoped
Procedures written to the old Part 820 vocabulary need to map to ISO 13485 clauses without losing the FDA-specific requirements that survived.
The DHF is assembled, not maintained
Design inputs, outputs, reviews, verification and validation live in separate tools, so the file is rebuilt for every audit and every change.
Risk Files Go Stale After Launch
ISO 14971 expects production and post-production information to feed back into risk, but complaints and CAPAs rarely reach the risk file.
Everything V5 does here5 capabilities
Design Controls with a Living DHF
Inputs, outputs, reviews, V&V and design transfer are linked objects with a traceability matrix that is always current — the DHF is a view, not a binder.
DMR and eDHR that match
The device master record drives the electronic device history record, so what was built is provably what was specified, unit by unit or lot by lot.
Complaints, MDR and CAPA in One Chain
A complaint carries reportability decision-making with the clock running, escalates to investigation and CAPA where justified, and closes with effectiveness evidence.
Risk management that stays live
Hazards, harms and controls per ISO 14971 link to design outputs, process controls, complaints and field data, so post-production information updates the risk file automatically.
Supplier Control and Purchasing Data
Approved supplier list, qualification evidence, incoming acceptance and supplier corrective action requests on the same record as the parts they affect.
Standards Referenced
- 21 CFR 820 — Quality Management System Regulation (QMSR, effective 2026)
- ISO 13485:2016 — medical device quality management systems
- ISO 14971:2019 — application of risk management to medical devices
- 21 CFR 803 — Medical Device Reporting
- 21 CFR Part 11 — electronic records and signatures
- EU MDR 2017/745 and UK MDR 2002 (UKCA)
Common questions5 answers
- What changes under QMSR versus the old Part 820?
- FDA incorporates ISO 13485:2016 by reference and keeps a set of US-specific requirements — labeling and packaging controls, complaint and servicing records tied to MDR, and record availability for inspection. Procedures need to speak ISO 13485 clause structure while preserving those FDA additions.
- Can one quality system serve FDA, CE and UKCA?
- Yes, and it should. The underlying records are largely shared; V5 tags evidence to the scheme being audited so a single DHF, risk file and CAPA record satisfies the FDA inspector, the notified body and the UK approved body.
- Does it produce an electronic DHR?
- Yes. The device master record drives the eDHR, enforcing the specified steps, components, checks and signatures per unit or lot, with deviations captured inline.
- How is Part 11 handled?
- Attributable, time-stamped audit trails on every record, enforced unique credentials, meaning-bound electronic signatures and controlled record retention — with Enterprise IQ/OQ and validation support; your team validates for its intended use.
- Do you support Class III and combination products?
- Yes. Design control depth, PMA-supporting evidence and drug-device combination requirements under 21 CFR 4 are all handled on the same record set.