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
Framework Quality & Manufacturing
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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Inspect-Ready the Modern WayThe procedures behind Part 820, read and acknowledged
01
Approve it, lock the version
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Every operator on record
Who read which revision, and when
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Answer the 483 before it is written
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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.
What AllyMatter does here
Document and record control layer only.
AllyMatter publishes this site.
Assessors
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: https://www.fda.gov/medical-devices/medical-device-single-audit-program-mdsap/auditing-organization-availability-conduct-mdsap-audits
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
Consultants
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. Listings we have not verified yet come from public filings and partner lists. Each firm can confirm its own.
No firm has claimed a FDA 21 CFR 820/QMSR consultant listing yet. Claim yours →
Software
Tools for FDA 21 CFR 820/QMSR
Tools that name this framework in their own material.
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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