US Medical Device Readiness: One Quality System From Clearance to Complaints
Classify the device, run one ISO 13485-based quality system under the QMSR, and keep complaints and reporting decisions on the record.
In Short
- QMSR applies since 2 Feb 2026.
- ISO 13485 plus FDA extras.
- Write audits expecting FDA to read them.
The Medical Device Production Guide
Built to revision. Inspected. On record.
- What the QMSR changed in February 2026
- Supplier to finished build
- Inspect, review, correct
We ask for your name and email so we can handle this request. The full guide then opens on this site, ready to translate, print or save. Privacy policy. Practical orientation, not legal advice; your quality unit decides which rules apply.
UltimateFree guide
The Medical Device Production Guide
Built to revision. Inspected. On record.
Selling a device in the United States means three things at once: the right premarket route (510(k), De Novo, PMA or exempt), a quality system that meets the Quality Management System Regulation, and postmarket processes for complaints, reporting and corrections. The QMSR has applied since 2 Feb 2026 and incorporates ISO 13485:2016 by reference. Sources checked 4 Oct 2026.
Start with classification
Device class and product code drive everything else: whether you need a 510(k), De Novo or PMA, whether design controls apply, and which special controls or standards FDA expects. Confirm the class from FDA's classification database and record the reasoning, because later changes are judged against it.
The QMSR in One Sentence
Under 21 CFR 820.10 you document a quality management system that complies with ISO 13485 plus the extra FDA requirements in Part 820. Those extras link ISO clauses to US rules: unique device identification under Part 830, tracking under Part 821 where applicable, complaint reporting under Part 803 and corrections and removals under Part 806.
Where the QMSR points beyond ISO 13485
| ISO 13485 clause | US rule it links to |
|---|---|
| 7.5.8 Identification | Unique device identification, Part 830 |
| 7.5.9.1 Traceability | Device tracking, Part 821, where applicable |
| 8.2.3 Reporting | Medical device reporting, Part 803 |
| 7.2.3, 8.2.3, 8.3.3 Advisory notices | Corrections and removals, Part 806 |
- 7.5.8 Identification
- US rule it links to
- Unique device identification, Part 830
- 7.5.9.1 Traceability
- US rule it links to
- Device tracking, Part 821, where applicable
- 8.2.3 Reporting
- US rule it links to
- Medical device reporting, Part 803
- 7.2.3, 8.2.3, 8.3.3 Advisory notices
- US rule it links to
- Corrections and removals, Part 806
Records FDA Now Reads Differently
Section 820.35 adds detail to complaint and servicing records: device name, date received, any UDI or UPC, the complainant, the nature of the complaint, investigation dates and results, and any reply. Management review, internal audit and supplier audit reports are no longer shielded from inspection the way they were under the old rule, so write them expecting an investigator to read them.
Production and process controls in practice
On the floor the questions are familiar: was the operator trained, was the equipment calibrated and maintained, did the build follow the approved revision, were inspections done and recorded, and is nonconforming product segregated with a documented decision. Keep the device production record traceable to component lots and the label applied.
Postmarket: complaints, MDRs and changes
Every complaint is reviewed to decide whether it is reportable under Part 803 and whether it needs investigation. Corrections and removals may need a Part 806 report.
Worked Example: One Complaint
- Day 0Complaint CP-118 received with device UDICustomer service
- Day 1Reviewed for MDR reportability; decision recordedRegulatory
- Day 5Investigation links lot, build record and test dataQuality
- Day 12CAPA opened; reply sent and recordedQuality
More on postmarket: complaints, MDRs and changes
Design and labeling changes go through change control, and you decide, with documented rationale, whether a change needs a new 510(k). Your regulatory team makes those calls; software only keeps the evidence together.
Questions
When did the QMSR take effect?
2 February 2026. It replaced the old Quality System Regulation text in 21 CFR 820 and incorporates ISO 13485:2016 by reference.
Does ISO 13485 certification satisfy FDA?
No. FDA does not accept certificates in place of inspection, and Part 820 adds US-specific requirements such as UDI, complaint record content and reporting links.
Do class I devices need design controls?
Most class I devices are exempt, but the classes listed in 820.10(c), including devices automated with software, still need them. Check your product code.
Where does V5 fit?
V5 keeps controlled documents, training, equipment records, device production records, deviations, complaints and CAPA linked. It does not choose a regulatory pathway, decide reportability or submit to FDA.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
Keep reading
Global medical device regulatory readiness (2026)
Australia Medical Device Regulatory Readiness Guide
Brazil medical device regulatory readiness guide (ANVISA)
Canada Medical Devices Regulations (SOR/98-282) Readiness
China Medical Device Regulatory Readiness Guide 2026
EU MDR medical device regulatory readiness (European Union)