The Complaint File and the CAPA System Disagree
Complaints are closed individually as no-trend, and the trending analysis that would have shown a trend was never run. An auditor reads the two records side by side and finds the gap inside an hour.
Medical Devices
The most heavily instrumented quality system there is, and since February 2026 the one where the American regulation and the international standard finally say the same thing.
FDA · United States
ISO · International
EU · MDR
The Shape of It
Design controls, risk management, and CAPA are the spine. What separates a system that passes from one that does not is usually neither of those — it is whether the post-market side is real, and whether the technical file, the label, and the UDI record agree with each other when somebody puts all three on the table.
Since February 2, 2026, the FDA route and the notified-body route rest on the same standard, which is a simplification worth having. It is not the same as being finished: the FDA deliberately kept several duties outside ISO 13485, and an inspection now takes a different path through your files than QSIT did.
What Applies
14 Documents an Auditor Is Likely to Open
The working set, not an exhaustive register. Each row prints the body that issues it, so nothing here depends on the color of the rule beside it. Customer-specific requirements sit on top of all of it and are frequently where the real work is.
FDA · US
21 CFR 820
QMSR. Since February 2, 2026, incorporates ISO 13485:2016 by reference with ISO 9000:2015 for terminology. QSIT retired; compliance program 7382.850 replaces 7382.845 and 7383.001.
FDA · US
21 CFR 803
Medical Device Reporting. Thirty-day and five-day reports. The complaint file is where every one of them starts.
FDA · US
21 CFR 806
Corrections and Removals. What has to be reported when you fix something already in the field, and when it does not.
FDA · US
21 CFR 830
Unique Device Identification. Device identification and GUDID submission — the record most often out of step with the label.
FDA · US
21 CFR 11
Electronic Records and Signatures. Audit trails, system validation, and who is permitted to change what.
ISO · Intl
ISO 13485:2016
QMS for Medical Devices. Now the substance of both the US and the EU routes rather than only the second.
ISO · Intl
ISO 14971:2019
Risk Management. Across the lifecycle. Everything else in the file hangs off it, including post-market.
IEC · Intl
IEC 60601-1
Electrical Medical Equipment. Basic safety and essential performance, plus its collateral and particular standards.
IEC · Intl
IEC 62366-1
Usability Engineering. Use error treated as a design input, not as a training problem.
IEC · Intl
IEC 62304
Software Lifecycle. Applies to software inside a device and to software that is itself the device.
EU · MDR
MDR Annex I
General Safety and Performance Requirements. The checklist your technical file is indexed against, clause by clause.
EU · MDR
MDR Art. 83–92
Post-Market Surveillance. PMS system and plan, PMS report or PSUR by class, trend reporting, and vigilance at 2, 10, and 15 calendar days.
EU · MDR
EUDAMED
Registration. Four modules mandatory from May 28, 2026; devices already on the market by November 28, 2026.
ISO · Intl
MDSAP
Single Audit Program. One audit accepted by five regulators. Worth the preparation if you sell into more than two of them.
Every standard above has a page and a free brief on QES letterhead, with its status as checked on October 24, 2026. Browse Standards & Guidance.
In Practice
Three Things That Usually Go Wrong Here
Not statistics — QES's own reading of where these systems are most often found short, from thirty years of building and auditing them.
Three Records of the Same Device, Written by Three People
The technical file, the artwork and the UDI submission were each correct when they were written, at three different times. Nobody has put all three on one table since.
Post-Market Surveillance Is a Document Rather Than a System
The PMS plan exists and is signed. Nothing in the last two years shows it was actually fed — no inputs logged, no periodic review, no decision recorded either way.
A Real-World Case
A Foam That Broke Down, and a Signal That Came Early
The Philips Respironics sleep and respiratory device recall is the clearest recent example of what post-market surveillance is for.
15 milliondevices affected worldwide, per FDA
- What Happened
- In June 2021, Philips Respironics recalled certain ventilators, BiPAP, and CPAP machines made between 2009 and April 26, 2021. The polyester-based polyurethane foam used to reduce sound and vibration can break down, and particles or chemicals could be breathed in or swallowed. FDA classified it as a Class I recall, the most serious type.
- What the Investigation Found
- FDA inspected the Murrysville, Pennsylvania facility between August and November 2021. Among the findings FDA summarized, an incorrect, non-specified raw foam had been used to build certain Trilogy Evo ventilators. Philips had identified 30 medical device reports from 2011 to April 2021 as associated with foam breakdown.
- What It Cost
- By FDA’s January 31, 2024 update, it had received more than 116,000 medical device reports, including 561 reports of death, reportedly associated with the foam; FDA notes that such reports alone cannot establish cause. On April 9, 2024, a federal court entered a consent decree restricting, with limited exceptions, the production and sale of new CPAP and BiPAP machines at several Philips Respironics facilities until requirements are met.
Sources. FDA — Recalled Philips ventilators, BiPAP machines, and CPAP machines (opens in a new tab); FDA — FDA activities related to the recall (opens in a new tab); FDA — Problems reported (update of January 31, 2024) (opens in a new tab). A public case, summarized from the official findings and reporting cited; QES was not involved in it. Figures are quoted as published. Checked October 24, 2026.
“Marcia & I worked together debugging and overhauling a variety of company procedures and work instructions to eliminate ambiguity, mitigate risk, and ensure quality in compliance with ISO and other regulatory requirements.”
Where to Start
Against the Clause, Not Against a Feeling
A fixed-price gap assessment — two days on your floor and in your files, from $4,800 — produces a clause-by-clause table: what you have, what the standard in your column actually requires, what is missing, and what has to be written — with an owner and a date against each line. You keep the findings whether or not you engage further.
On This Page. The standards listed are the working set an auditor is most likely to open, not an exhaustive register. Dated statements are sourced on the research page. The experience described is drawn from Marcia Weeden's employment record and is available in full on her résumé. Canceled military specifications are marked as canceled where they are still cited in contract flowdowns. Checked October 24, 2026.