Cannon Quality GroupDanville, California, USA
- What they do
- Compliance consulting
- Who they help
- Its website offers consulting for FDA QSR / QMSR (21 CFR 820), ISO 13485, GMP / cGMP, HACCP, IEC 60601 and more.
- Standards
- Pricing
- Not published
FDA 21 CFR 820/QMSR
21 CFR Part 820 is the FDA regulation for medical device quality systems. On February 2, 2026 it became the Quality Management System Regulation (QMSR), replacing the older Quality System Regulation.
The QMSR incorporates ISO 13485:2016 by reference and adds FDA-specific requirements where the standard is silent or differs, for example on complaint handling tied to medical device reporting, unique device identification and labeling controls, and record retention and confidentiality.
FDA also replaced its inspection approach with a new compliance program (7382.850) on the same date.
In writing, a manufacturer must now hold everything ISO 13485 asks for (quality manual, documented procedures, device master records equivalent, design history files, risk management files, supplier controls, CAPA, complaint files) plus the FDA supplements. Design controls, process validation, and CAPA remain the areas FDA cites most often.
An ISO 13485 certificate does not substitute for FDA compliance, but manufacturers audited under MDSAP may have that audit accepted in place of routine FDA surveillance inspection.
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Who has to comply
Finished device manufacturers (and certain specification developers, contract manufacturers, relabelers, and importers as defined) that commercially distribute medical devices in the United States, domestic or foreign.
Some Class I devices are exempt from design controls; component suppliers are generally not directly regulated but are controlled through the manufacturer's supplier requirements.
What the assessor asks to see
Quality manual and QMS scope with ISO 13485 mapping; management responsibility and review records; design and development files including design inputs, outputs, verification, validation, transfer, and changes; risk management file (ISO 14971); document and record controls; purchasing and supplier controls; production and process controls, process validation, and equipment records; identification and traceability including UDI; labeling and packaging controls; complaint handling and medical device reporting decisions; CAPA records; nonconforming product; servicing and installation records where applicable; internal audits; training and competence records; statistical techniques.
Where the requirement sits: 820.10 incorporates ISO 13485; 13485 4.2.4/4.2.5
QMSR effective date and what changed
The QMSR final rule was published February 2, 2024 and took effect February 2, 2026 with no phased transition. Part 820 is now short: it incorporates ISO 13485:2016 by reference and keeps FDA-specific clauses on scope, definitions, control of records, device labeling and packaging, and complaint and servicing records.
Terms such as design history file and device master record are gone from the regulation text, but the underlying records are still expected under ISO 13485 clauses. Manufacturers do not need an ISO 13485 certificate to comply; FDA inspects directly.
Every internal policy in one place
AllyMatter is a full system for every internal policy your company keeps, including the ones FDA 21 CFR 820/QMSR turns on. Build the whole library in one place, across every department, and prove who has read what.
Start here
ISO 9001 Quality Policy and Documented Information: who needs it, what goes in it, how often it is reviewed and who signs it off. Run exactly that in AllyMatter, alongside every other policy your company keeps.
How it works
Every document is approved by someone other than its author, versioned, distributed to the people it covers and acknowledged by name. Sign it where a signature is what the standard wants, send a set out together as a package, and export a dated record of who read which version when an assessor asks.
The written policies this standard turns on live here, with every version and every acknowledgment on the record.
Who helps with FDA 21 CFR 820/QMSR
A very mature medical device quality and regulatory consultant ecosystem exists. Consultants run QMSR gap assessments against the old QSR mapping, rewrite the quality manual and procedures to ISO 13485 language, remediate design history files and risk files, run mock FDA and MDSAP audits, and manage 483 and warning letter responses.
Transition projects in 2025 and 2026 typically ran three to nine months.
Firms that name this framework in their own material. A listing is not a recommendation. Each firm can confirm its own.
Listed in random order, reshuffled each time the page loads. Firms that pay for a listing are shown at the top, labeled Sponsored.
Martin Quality Consulting LLCPelham, New Hampshire, USA
- What they do
- Compliance consulting
- Who they help
- Its website offers consulting for 21 CFR Part 820 (QMSR), ISO 13485, 21 CFR Part 11, EU IVDR 2017/746, EU MDR 2017/745 and more.
- Standards
- Pricing
- Not published
Who assesses FDA 21 CFR 820/QMSR
FDA investigators (government inspection). MDSAP-recognized auditing organizations conduct audits that FDA accepts in lieu of routine surveillance inspections for participating manufacturers. for FDA inspection.
MDSAP auditing organizations are recognized by the MDSAP regulatory authority council (FDA, Health Canada, TGA, ANVISA, MHLW/PMDA).
Public register of assessors: fda.gov ↗
Listed in random order, reshuffled each time the page loads. Firms that pay for a listing are shown at the top, labeled Sponsored.
BSI Group America Inc.On the public register
- What they do
- Assessor
- Which standards
- On the public register for FDA 21 CFR 820/QMSR, ISO 13485.
- Standards
- Pricing
- Not published
DEKRA Certification B.V.On the public register
- What they do
- Assessor
- Which standards
- On the public register for FDA 21 CFR 820/QMSR, ISO 13485.
- Standards
- Pricing
- Not published
DNV Product Assurance ASOn the public register
- What they do
- Assessor
- Which standards
- On the public register for FDA 21 CFR 820/QMSR, ISO 13485.
- Standards
- Pricing
- Not published
DQS Medizinprodukte GmbHOn the public register
- What they do
- Assessor
- Which standards
- On the public register for FDA 21 CFR 820/QMSR, ISO 13485.
- Standards
- Pricing
- Not published
Intertek Testing Services NA Inc.On the public register
- What they do
- Assessor
- Which standards
- On the public register for FDA 21 CFR 820/QMSR, ISO 13485.
- Standards
- Pricing
- Not published
Tools for FDA 21 CFR 820/QMSR
Tools that name this framework in their own material.
Grouped by type. Inside each group the order is random, reshuffled each time the page loads. AllyMatter, the publisher of this site, is always first.
AllyMatterPolicy management tool, the policy and acknowledgment layerPublisher of this siteQMS and EQMS suites2 tools
Document control for quality systems; ISO 9001, 13485 and AS9100 shops.
Related reading
- February 2, 2026 is quickly approaching - are you QMSR ready?Practical readiness piece on what changes when Part 820 incorporates ISO 13485, including the FDA-specific additions the standard does not cover.Morgan Lewis
- Major shift for QMSR transition for medical device applicationsCovers FDA's late change of course on how QMSR applies to pending device submissions, a detail most overviews miss.Alston & Bird
- FDA releases final rule harmonizing the Quality System Regulation with ISO 13485Contemporary account of the final rule, useful for understanding why FDA kept some Part 820 requirements outside the standard.Regulatory Affairs Professionals Society
Independent third-party explainers, chosen by hand. Not affiliated with this site and not paid placements. All links are nofollow.
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Approve the policies FDA 21 CFR 820/QMSR asks for, keep every version, and record a named acknowledgment from each person who has to read them.
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