FDA QMSR · Feb 2026 · ISO 13485:2016 · 21 CFR 820 · One Platform
QMSR software organised around the FDA's harmonized rule and ISO 13485:2016.
The FDA Quality Management System Regulation (QMSR) — the harmonized replacement for 21 CFR 820 — became effective 2 February 2026. No re-architecture, no scramble, no gap-analysis panic.
eDHR / DMR / DHF
CAPA with Effectiveness
ISO 14971 Risk Management
Training-to-Role
Full product detailCommon problems, what's included, why teams choose it, and where commercial meets regulated.
You're shopping for QMSR software because Feb 2026 is on the calendar and your QMS was built for 1996.
Your QMS is written to the old §820 subparts, not the ISO 13485 clause map
DHR, DMR and DHF live in three tools that don't know each other exist
Risk management (ISO 14971) is a Word document, not a live linkage to CAPAs and complaints
Design controls and post-market feedback don't close the loop
Your CAPA effectiveness check is an email thread, not a scheduled control
You have no evidence pack that reads under both the old §820 and the new QMSR
What's included
eDHR / DMR / DHF
Device History Record, Master Record and History File as one linked object model — not three binders. Every build, every rev, every change traceable end-to-end.
CAPA with Effectiveness
Root cause, action plan, verification, effectiveness check on a scheduled timer — not a promise. Signed under Part 11, linked to complaints, NCRs and design changes.
ISO 14971 Risk Management
Risk file lives inside the QMS. Hazards, harms, controls and residual risk are linked to the design outputs, CAPAs and complaints that change them.
Training-to-Role
Curriculum by role, competence evidence, and current-training check at every Part 11 signature. Retraining triggered by SOP or work-instruction changes.
Design controls (Clause 7.3)
Design inputs, outputs, review, verification, validation, transfer, change — one traceability matrix, not a spreadsheet reconstructed the week before audit.
Post-Market Surveillance
Complaints, MDRs, field actions and recall linkage feed CAPA and risk. The feedback loop the QMSR preamble specifically calls out.
What QMSR readiness looks like — not a re-implementation.
- Your ISO 13485 evidence is your QMSR evidence — one instance, one audit
- Design controls, risk, CAPA and post-market feedback close the loop natively
- Audit trail and e-signature records your QA can review and export for an inspection
- Independent 21 CFR Part 11 / 21 CFR 211 assessment of V5 Ultimate 5.10 (Sept 2026)
The regimes device manufacturers actually get inspected against.
FDA QMSR (effective Feb 2026)
Harmonized rule incorporating ISO 13485:2016 by reference, with FDA-specific additions (Part 803 MDR, Part 806 corrections/removals, Part 820 labeling). V5's object model already maps to the harmonized clause structure.
ISO 13485:2016
Full clause coverage: 4 QMS, 5 management responsibility, 6 resources, 7 product realization (design controls, purchasing, production, sterilization, servicing), 8 measurement, analysis and improvement.
ISO 14971:2019
Risk management file linked to design outputs, CAPAs and complaints. Residual risk and benefit-risk determinations evidenced, not asserted.
21 CFR Part 11
Bound e-signatures, hash-chained audit trail, RBAC with author-cannot-self-approve. Supports your Part 11 approach; validation stays yours.
EU MDR / IVDR Bridge
The same ISO 13485-aligned instance carries EU MDR (2017/745) and IVDR (2017/746) technical documentation obligations for CE-marked devices.
QMSR software, answered.
What is QMSR and when does it take effect?
The Quality Management System Regulation (QMSR) is the FDA's replacement for the 21 CFR 820 Quality System Regulation. It incorporates ISO 13485:2016 by reference and adds a small set of FDA-specific requirements.
Do we still need Part 820 if we have ISO 13485?
Under QMSR, most of §820's structural requirements are replaced by ISO 13485:2016 by reference. Some FDA-specific requirements remain (MDR under Part 803, corrections and removals under Part 806, labeling and UDI). V5 covers both the ISO clauses and the remaining Part 820 obligations on one platform.
Is our existing ISO 13485 evidence still valid?
Yes — and that is the point of harmonization. A well-run ISO 13485:2016 QMS is close to QMSR-ready today. What often needs work is closing the loop between risk (14971), CAPA, complaints and design changes. V5 models that loop natively.
Do we have to re-validate our QMS for QMSR?
You do not have to re-validate the underlying software. You do need to update procedures to reference the harmonized clause structure and to confirm CAPA, risk, MDR and design-control linkages meet the new expectations. V5's clause map and evidence packs are delivered QMSR-ready.
What about EU MDR and IVDR?
The same ISO 13485-aligned instance carries the technical documentation obligations for CE-marked devices under EU MDR (2017/745) and IVDR (2017/746). One QMS, both markets.
Capabilities vary by plan and setup. Confirm specifics with our team before relying on them.
Run your QMSR records on one platform — without re-architecting your QMS.
Free trial.