QMSAdvisor

Audit readiness for US medical device manufacturers

Get Audit‑Ready Without Weeks of Digging Through Scattered Quality Documents

QMSAdvisor turns the quality documents you already have into a clear audit-readiness plan. AI does the first-pass heavy lifting. A qualified QMS advisor reviews, decides and approves every finding.

Request an assessmentSee the inspection simulator
  • No migration. Keep your QMS.
  • Findings with sources
  • Every result advisor-reviewed
An MRI scanner in a bright imaging suite, with a laptop showing scan images in the foreground

The Problem

Your Quality System Exists. Proving It Takes Weeks.

Most quality teams don't lack procedures. They lack time to read hundreds of documents against the requirements, find the gaps and the contradictions, and show an investigator a clean line from requirement to record. That work usually lands on the same few people who run the quality system day to day.

  • Procedures live on a shared drive, records in another system, and the latest revision is in someone's inbox.
  • Nobody has read every SOP against QMSR since it took effect on February 2, 2026.
  • Internal audit, management review and supplier audit records are now open to FDA, and they were written for an internal audience.
  • The last gap assessment produced a spreadsheet that nobody owned after the consultant left.
QMSAdvisor/ Findings / F-014
F-014HighInsufficient evidenceAdvisor issued

Complaint files do not record the MDR reportability decision

Requirement
Complaint handling under QMSR and ISO 13485; 21 CFR Part 803
Source
SOP-QA-012 rev C, complaint evaluation section
Owner
QA Manager
Due
In 21 days

What to submit

  • Submitted: Revised complaint handling procedure with a reportability decision step
  • Submitted: Training record for complaint handlers on the revised procedure
  • Not yet submitted: Five recent complaint files showing the documented decision
Evidence 2 of 3 submittedAwaiting advisor review
Illustrative example. Sample data, not a real client.

How It Works

From Scattered Documents to Accepted Evidence

AI handles the first pass. People handle every decision. Your team always knows what to do next and why.

  1. Step 1: Documents

    Upload the quality documents you already have: procedures, records, spreadsheets and exports from your current eQMS. Nothing is migrated or rewritten. Original files are preserved and fingerprinted.

    You

  2. Step 2: AI First Pass

    AI-assisted gap analysis reads every document against QMSR, ISO 13485 and the standards in scope, and drafts candidate gaps. Each one points to the document and passage it came from.

    AI first pass

  3. Step 3: Advisor Review

    A qualified QMS advisor reviews every draft, discards what doesn't hold up, adds what software can't judge and sets severity. Nothing reaches you until the advisor publishes it.

    Advisor

  4. Step 4: Findings

    Advisor-reviewed findings, each with the requirement, the source, a severity, a gap type and a plain checklist of what to submit to close it.

    Advisor

  5. Step 5: Client Action Plan

    Findings become a working plan with owners, due dates and evidence requirements, sorted so the riskiest gaps are handled first.

    You and your advisor

  6. Step 6: Evidence

    Your team submits evidence against each finding: a revised procedure, a training record, a completed validation. A resubmission has to say what changed.

    You

  7. Step 7: Advisor Approval

    The advisor accepts the evidence or returns it with a note. Every decision is written to an activity history that can't be edited after the fact.

    Advisor

  8. Step 8: Audit Readiness

    A readiness view by area, a rehearsal in the inspection simulator, and a record that shows an auditor exactly how each gap was found and closed.

    You and your advisor

The dashed label marks the only step software does on its own. Every step after it runs through a person.

Services

Help for Every Stage of Audit Readiness

Start with a gap assessment, prepare for a specific audit or inspection, respond to a 483, or keep your system ready year-round.

All services

Assessments

FDA Inspections and Enforcement

Quality System Remediation

Certification and Market Access

Build and Ongoing Support

Not sure where to start?

We usually recommend starting with an AI-assisted QMS gap assessment. An advisor will tell you if something else fits better.

About the gap assessment

Audits and Inspections

Know What's Coming and Prepare for It

What each audit or inspection is, who runs it, what triggers it and what gets examined. Since February 2, 2026, FDA inspects device makers under QMSR and Compliance Program 7382.850.

All audits

FDA Inspections

Certification and Regulatory Audits

Customer, Supplier and Internal Audits

FDA Inspection Simulator

Rehearse the Inspection Before the Investigator Arrives

Your advisor plays the investigator. Document requests run on the clock, your back room produces from your own library, interviews are scored for answer discipline, and practice observations are listed at closeout in a 483-style list. It's a rehearsal, never an FDA document, and it's something most quality software doesn't offer.

  • Scoped by the 6 QMS areas and 4 other requirements in CP 7382.850
  • Preloaded document requests and interview questions
  • Response clock on every request
  • Simulated NAI, VAI or OAI outcome
See how the simulator worksBook a mock inspection
QMSAdvisor/ Inspection simulator / Day 1 / Requests

Document requests

Investigator: AdvisorScope: CP 7382.850, 6 QMS areas
IDRequestClockStatus
R-07Three closed CAPA records with effectiveness checksMeasurement, Analysis, and Improvement00:42:10In back room
R-06Quality agreement for sterilization supplierOutsourcing and Purchasing00:18:55Produced
R-05Process validation for the sealing processProduction and Service Provision01:05:30Returned: not adequate
R-04Minutes of the two most recent management reviewsManagement Oversight00:12:04Accepted
R-03Change log for the inspection periodChange Control00:09:41Accepted
Illustrative example. A practice exercise, not an FDA document.

Who We Serve

Built Only for Medical Device, Supply and Equipment Companies

From Class I to Class III, from gloves and dressings to hospital beds and imaging systems, and from manufacturers to distributors, relabelers and reprocessors. Medical only.

Everyone we serve

Standards and Regulations

Mapped to the Requirements Auditors Use

The AI first pass and the advisor review work against QMSR, ISO 13485 and the standards and regulations that apply to your devices. Plain-language guides to each are free to read.

StandardsRegulations

Why Advisor-Reviewed AI

The Speed of Software, the Judgment of an Advisor

AI is good at reading everything. It isn't accountable for a judgment call. QMSAdvisor puts each to work where it belongs.

How QMSAdvisor compares with software-only AI analysis and traditional consulting
CapabilitySoftware-only AI analysisTraditional consultingQMSAdvisor
Reads every documentYesSamples, as time allowsYes, in the AI first pass
Decides what is a real gapYour own teamThe consultantA qualified advisor reviews every finding
Shows the source of each findingDepends on the toolDepends on the consultantDocument and passage on every finding
Requires moving your QMSOftenNoNo
Independent acceptance of your evidenceNoInformal, by emailAdvisor accepts or returns, with a recorded reason
Record of how each gap was closedDepends on the toolSpread across email and filesActivity history that can't be edited
Inspection rehearsalRarelyIn person, if bookedFDA Inspection Simulator

General comparison of approaches, not of any specific product or firm.

Questions

Common Questions

About the service, the platform, AI, inspections and how engagements work.

All questions

Do we have to move our quality system into new software?

No. We work from the documents you already have, in whatever form they are in: files on a shared drive, spreadsheets, or exports from the eQMS you use today. Your system of record stays where it is.

Does AI replace the consultant?

No. AI takes on the slow part, reading hundreds of documents and cross-checking them. The judgment calls, such as whether something is a real gap, how serious it is and whether your evidence closes it, are made by a qualified advisor.

How are FDA device inspections run now?

Since February 2, 2026, FDA inspects device manufacturers under the Quality Management System Regulation and Compliance Program 7382.850, which replaced the QSIT approach. Requirements are grouped into six QMS areas plus four other FDA requirements, and inspections are risk-based, starting from your risk management documentation.

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

FDA asks for a written response within 15 business days after the inspection closes for the response to be considered before further action. The platform tracks that countdown from the day you enter the close date.

Can you guarantee we will pass our audit or inspection?

No, and no one honestly can. Outcomes are decided by FDA investigators, notified bodies and certification bodies. What we can do is find your gaps early, help you close them with evidence that stands up, and rehearse the inspection so your team is prepared.

How much does it cost?

Engagements are scoped after an assessment call, because the work depends on your devices, the size of your quality system and the audit or inspection ahead. You'll get a written scope before any work starts.

Request an Assessment

Turn Scattered QMS Documents Into a Clear Audit-Readiness Plan

Tell us about your devices, your documents and the audit or inspection ahead. An advisor will follow up to scope an assessment. Please don't send confidential documents yet: secure upload is set up after onboarding.

Request an assessmentRead the FAQ