FDA QMSR Consulting and 21 CFR 820 Consultants

MedDeviceCorp provides FDA QMSR consulting (formerly the QSR) for medical device manufacturers that sell in the United States. Our 21 CFR 820 consultants audit your quality system, prepare you for FDA inspections, write Form 483 and warning letter responses, and move older QSR-based systems to the new Quality Management System Regulation (QMSR). We also support drug and dietary supplement makers under 21 CFR Parts 211 and 111. Our teams work from offices in India, the USA and the UK.

Reviewed by Luke Fernandaz · Last updated: October 2026

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Our FDA QMSR Consulting Services

QSR / QMSR gap audit

A full audit of your system against 21 CFR Part 820 and ISO 13485:2016, with a written report of every gap and its risk at inspection.

Mock FDA inspection

A realistic inspection run the way an FDA investigator would, including document requests, interviews and a closing meeting.

QMSR transition

Rewriting QSR-era procedures, records and terminology so your system meets the QMSR that has applied since 2 February 2026.

Form 483 response

Root cause analysis, corrective actions and a response letter submitted within FDA's 15 business day window.

Warning letter remediation

Remediation plans, CAPA support and progress reports until FDA closes the warning letter.

Implementation support

Help building or fixing CAPA, complaint handling, design controls, supplier controls and production records.

What Is the FDA QSR (21 CFR Part 820)?

The Quality System Regulation, usually called the QSR, is the FDA's current good manufacturing practice (CGMP) rule for medical devices. It sits in Title 21 of the Code of Federal Regulations, Part 820, and covers the methods, facilities and controls used to design, make, package, label, store, install and service finished devices sold in the United States.

The QSR applied from 1997 until 1 February 2026. On 2 February 2026 it was replaced by the Quality Management System Regulation (QMSR), which keeps Part 820 but builds it around ISO 13485:2016. Most people still search for "FDA QSR", and many companies still run procedures written for it, so a large part of our work is bringing those systems up to date.

From QSR to QMSR: What Changed in 2026

The FDA published the QMSR final rule on 2 February 2024 and gave manufacturers two years to comply. The main changes are:

Topic	Old QSR	QMSR (from 2 Feb 2026)
Core requirements	FDA's own text in subparts A to O	ISO 13485:2016 incorporated by reference, plus FDA additions
Risk management	Mentioned mainly in design validation	Expected across the whole quality system, as in ISO 13485
Records	DHF, DMR, DHR and QSR terms	ISO 13485 terms such as the medical device file; specific FDA content for complaint, servicing and UDI records
Labelling and packaging	Subpart K	Kept as an FDA-specific requirement in section 820.45
Management review, internal and supplier audit reports	Normally not reviewed by FDA investigators	Can now be reviewed during inspections

The last point matters most in practice. Investigators can now read your management review minutes and audit reports, so weak or missing records are much easier to find. FDA has also updated its inspection program for the QMSR and moved away from the older QSIT inspection model.

Official source: 21 CFR Part 820 (QMSR) on eCFR.

Who Must Comply with 21 CFR 820?

Part 820 applies to manufacturers of finished medical devices intended for sale in the United States, including foreign manufacturers that export to the US. In practice this covers:

Legal manufacturers and specification developers
Contract manufacturers and contract sterilisers
Repackagers, relabellers and remanufacturers
Manufacturers of accessories and software as a medical device

Makers of components or parts are not directly subject to Part 820, but their customers must control them as suppliers. Some Class I devices are exempt from most of Part 820, though record-keeping and complaint file requirements usually still apply. Check your device's classification regulation to see which apply.

Before you can sell, your establishment must also be registered and your devices listed. See our US FDA registration and US FDA Agent services for foreign manufacturers.

Key 21 CFR 820 Requirements FDA Investigators Check

Whatever the regulation is called, FDA inspections keep returning to the same areas:

Area	What investigators look for
Management responsibility	Quality policy, resources, management review and its actions
Design controls	Design inputs, verification, validation, risk files, design transfer and design changes
CAPA	Data analysis, root cause investigation, effectiveness checks and links to complaints and nonconformities
Complaint handling	Timely evaluation, investigation and decisions on medical device reporting
Production and process controls	Process validation, equipment, environment and change control
Purchasing and supplier controls	Supplier evaluation, agreements and monitoring based on risk
Labelling and packaging	Label review, release and mix-up prevention
Records	Device history, traceability and UDI data

Inspections also cover linked regulations such as medical device reporting (21 CFR 803), corrections and removals (21 CFR 806) and unique device identification (21 CFR 830).

FDA QMSR Audit and Gap Analysis

A QSR audit, or QMSR gap analysis, shows where your system stands before FDA does. Our auditors review your procedures and sample real records across every area above, including the management review and audit records that investigators can now see.

You receive a report that lists each finding by section, the evidence reviewed, how likely it is to be cited on a Form 483 and the action needed to close it. Our gap analysis is priced per man-day and covers the audit and report. Implementation help is quoted separately.

Mock FDA Inspections

A mock inspection tests your people as well as your paperwork. Our consultants play the role of the investigator. We open with a meeting, request documents, tour the facility, interview staff and close with a list of observations written the way a Form 483 would be.

It is the best preparation for a first inspection, a pre-approval inspection for a PMA device, or a follow-up inspection after earlier findings. We also coach your front-room and back-room teams on how to host an inspection.

Moving a QSR System to the QMSR: A Practical Plan

Most companies do not need to rebuild their quality system. They need to map it, close the gaps and update the language. Our usual plan is:

Map procedures to ISO 13485. Link each existing SOP to the ISO 13485 clause it meets and list anything not covered, such as risk management across the QMS or software validation for QMS tools.
Update terminology. Replace QSR terms like design history file and device master record with ISO 13485 terms, or explain how they correspond, so investigators can follow your records.
Check FDA-specific additions. Confirm labelling and packaging controls, complaint and servicing records and UDI records meet the QMSR wording.
Strengthen audit records. Make management review minutes and internal and supplier audit reports ready to be read by FDA.
Train and verify. Train staff on what changed and run an internal audit against the QMSR before your next inspection.

FDA Inspection Readiness Checklist

Before an investigator arrives, make sure you can answer yes to each of these:

A named person and a backup are ready to host the inspection, with a document room and a scribe
Your quality manual, organisation chart and procedure list can be produced within minutes
CAPA records show root cause, actions and effectiveness checks, and are linked to trends
Every complaint has a documented decision on whether it is reportable under 21 CFR 803
Process validations are current and cover every process whose output cannot be fully verified
Design history and risk files are complete for each device on the market
Supplier files show evaluation, agreements and monitoring for critical suppliers
Training records show staff are competent for the procedures they follow
Management review and internal audit records are complete, signed and acted on
Registration, listing and UDI data in FDA databases match your current devices

If several answers are no, a gap audit followed by a mock inspection is the quickest way to close them.

Types of FDA Inspection

Each type of inspection has a different focus, so preparation should match it.

Routine surveillance

Risk-based inspections of registered establishments to check ongoing compliance.

Pre-approval

Carried out before FDA approves a PMA, focusing on design and manufacturing of that device.

For-cause

Triggered by complaints, recalls, adverse events or other signals of a problem.

Compliance follow-up

Checks that corrections promised after a 483 or warning letter have actually been made.

Inspections of foreign sites are usually announced in advance, while inspections of US sites often are not. FDA classifies the outcome as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI).

FDA Form 483 Response

A Form 483 lists the investigator's inspectional observations at the end of an inspection. It is not a final agency decision, but how you respond decides what happens next. FDA considers responses received within 15 business days before deciding whether to issue a warning letter.

Our 483 response service includes:

Review of each observation and the evidence behind it
Root cause analysis that looks beyond the single example cited
Corrections, corrective actions and a realistic timeline
A clear response letter with supporting evidence
Follow-up updates to FDA until all actions are complete

FDA Warning Letter Remediation

A warning letter is issued when FDA considers violations significant, often after a weak or late 483 response. It is published on the FDA website and can lead to import alerts, refusal of export certificates or delays to new clearances until it is resolved.

We help you respond within the 15 business days given, build a remediation plan that addresses system-wide causes, carry out effectiveness checks and send progress reports until FDA issues a close-out letter.

Most Common 21 CFR 820 Inspection Observations

CAPA and complaint handling have been among the most cited areas in FDA device inspections for many years. Typical observations include:

CAPA procedures not followed, or no effectiveness check recorded
Complaints not evaluated for medical device reporting
Process validation missing for processes whose results cannot be fully verified
Design changes made without verification, validation or review
Supplier evaluation not documented or not based on risk
Procedures written but not established, meaning staff do not follow them

Our audits are built around these known problem areas so you can fix them first.

Is There an FDA QMSR (QSR) Certification?

No. The FDA does not certify quality systems, and there is no official QSR or QMSR certificate. Compliance is shown through FDA inspections. A clean inspection may end with no Form 483, and the outcome is recorded as NAI.

Many manufacturers also hold ISO 13485 certification from an accredited certification body, or take part in MDSAP, whose audit reports FDA can accept in place of a routine inspection. Because the QMSR is built on ISO 13485, one system can now serve all three. See our ISO 13485 consulting page for certification support.

How Our 21 CFR 820 Consultants Work

Scoping. We confirm your devices, sites, inspection history and deadlines.
Gap audit. On site or remote review of procedures and records against Part 820 and ISO 13485.
Report and plan. Findings ranked by inspection risk, with owners and dates.
Remediation. Procedures rewritten, records corrected and staff trained.
Mock inspection. A full rehearsal before FDA arrives.
Inspection support. Help during the inspection and with any 483 response.

21 CFR 820 Compliance Consultants Across the USA

We support device manufacturers in every US state remotely, with onsite audits and mock inspections arranged from our US office. Recent work includes clients in:

Region	Typical projects
Indiana, including Indianapolis	Orthopaedic and component suppliers, supplier controls, QMSR transition
California, including Los Angeles	Startups preparing for a first inspection, design controls
Texas, including Austin	Gap audits, CAPA and complaint handling remediation
Other states	Mock inspections, 483 responses and internal audits

Foreign manufacturers exporting to the US get the same services from our India and UK teams.

21 CFR Part 211: GMP for Finished Pharmaceuticals

Part 211, read with Part 210, sets the minimum current good manufacturing practice for finished drug products. FDA inspects registered drug facilities against it, and drugs made in non-compliant conditions are considered adulterated, whatever their test results.

Our Part 211 services cover pre-inspection audits, post-inspection consultation, 483 response preparation and submission, and CAPA follow-up with FDA. For drug filings, see our Drug Master File page.

Official source: 21 CFR Part 211 on eCFR.

21 CFR Part 111: GMP for Dietary Supplements

Part 111 sets CGMP requirements for manufacturing, packaging, labelling and holding dietary supplements. FDA inspections focus on identity testing of ingredients, specifications, master and batch production records, and complaint handling.

We offer Part 111 gap audits and 483 responses on the same basis as our device and drug services. For facility certification, see our GMP certification page.

Official source: 21 CFR Part 111 on eCFR.

FDA QMSR and GMP Consulting Fees

Timelines depend on the type of product, number of employees, number of products and manufacturing floor area.

Service	21 CFR 820 (devices)	21 CFR 211 (drugs)	21 CFR 111 (supplements)
GMP implementation service	On request	On request	On request
FDA pre-inspection gap analysis with report (no implementation guidance)	$500 per man-day	$600 per man-day	$500 per man-day
Closing of Form 483 observations	$400 per 483	$500 per 483	$400 per 483

Onsite consultants travel from our nearest office in India, the USA or the UK. Travel and lodging are charged extra.

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Related US FDA Services

FDA 510k consultants and 510k submission support
US FDA registration of establishments and device listing
US FDA Agent for foreign manufacturers
MDSAP audits covering the USA and four other markets
Biocompatibility testing for device submissions

Why Choose MedDeviceCorp for FDA QMSR Consulting?

Consultants experienced with 21 CFR 820, ISO 13485 and FDA inspections
Up to date on the QMSR and FDA's revised inspection approach
Published fees for audits and 483 responses
Offices in India, the USA and the UK, with remote support worldwide
One team for quality systems, FDA submissions and registration
Full addresses and contact details on our Contact page

FDA QMSR Consulting FAQs

What is FDA QSR?

FDA QSR is the Quality System Regulation in 21 CFR Part 820, the FDA's good manufacturing practice rule for medical devices. Since 2 February 2026 it has been replaced by the Quality Management System Regulation (QMSR), which is based on ISO 13485:2016.

What does an FDA QSR consultant do?

An FDA QSR consultant audits a device manufacturer's quality system against 21 CFR 820, helps fix gaps, prepares the company for FDA inspections and writes responses to Form 483 observations and warning letters.

Is the QSR still in effect?

No. The QSR was replaced by the QMSR on 2 February 2026. Part 820 still exists, but its requirements now come mainly from ISO 13485:2016 with some FDA-specific additions.

What is the difference between QSR and QMSR?

The QSR used FDA's own wording for each requirement. The QMSR incorporates ISO 13485:2016 by reference, adds FDA requirements for labelling, packaging and certain records, and allows investigators to review management review and audit reports.

Is there an FDA QSR certification?

No. FDA does not issue QSR or QMSR certificates. Compliance is checked through inspections. Companies often hold ISO 13485 certification or MDSAP reports as separate evidence of their quality system.

What is a QSR audit?

A QSR audit is an independent review of a device quality system against 21 CFR 820, usually done before an FDA inspection. It identifies gaps that could lead to Form 483 observations.

How much does an FDA QSR audit cost?

Our pre-inspection gap analysis for 21 CFR 820 is $500 per man-day, plus travel and lodging for onsite work. The number of days depends on your size and number of products.

How long do I have to respond to a Form 483?

There is no legal deadline, but FDA considers responses received within 15 business days before deciding on further action such as a warning letter. Responding inside that window is strongly recommended.

How much does it cost to close a Form 483?

Our fee is $400 per 483 for medical devices and dietary supplements, and $500 per 483 for pharmaceuticals.

What happens if a 483 response is not adequate?

FDA may issue a warning letter, carry out a follow-up inspection or take further action such as an import alert for foreign sites.

Does 21 CFR 820 apply to foreign manufacturers?

Yes. Foreign manufacturers of devices sold in the US must comply with Part 820 and can be inspected by FDA, usually with advance notice.

Do I need ISO 13485 to comply with the QMSR?

You do not need a certificate, but your system must meet ISO 13485:2016 requirements because the QMSR incorporates them. Certification is a separate, voluntary step.

Can FDA now see our internal audit reports?

Yes. Under the QMSR, FDA investigators can review management review, internal audit and supplier audit reports, which were normally excluded under the old QSR.

Do you offer mock FDA inspections?

Yes. Our consultants run full mock inspections on site, including document requests, staff interviews and a closing meeting with written observations.

Do you have 21 CFR 820 compliance consultants in Indiana?

Yes. We work with manufacturers in Indianapolis and across Indiana, both remotely and on site.

Do you work with companies in California and Texas?

Yes. We support device makers in Los Angeles, Austin and across both states, and in every other US state.

Are Class I devices exempt from 21 CFR 820?

Some Class I devices are exempt from most Part 820 requirements, but record-keeping and complaint file requirements usually still apply. The device's classification regulation states the exemption.

Do you also help with 21 CFR Part 211 and Part 111?

Yes. We provide gap audits, inspection support and 483 responses for drug manufacturers under Part 211 and dietary supplement makers under Part 111.

Prepare for Your Next FDA Inspection

Talk to our 21 CFR 820 consultants in India, the USA or the UK about a QSR audit, mock inspection or 483 response.

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