Frequently Asked Questions

We help medical device manufacturers get ready for audits and inspections, and fix what an audit or inspection found. AI does the first pass over your existing quality documents, a qualified QMS advisor reviews every result, and your team works through an advisor-reviewed action plan until the evidence is accepted.

US medical device manufacturers of any class, from startups preparing a first submission to established manufacturers facing an FDA inspection, an ISO 13485 or MDSAP audit, or a Form 483. Consulting firms can also use the platform to run several clients at once.

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.

Every engagement is led by a qualified QMS advisor with medical device quality and regulatory experience, who reviews and signs off every finding. You'll know who your advisor is before the engagement starts.

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.

Your document library, the advisor-reviewed findings, your action plan with owners and due dates, and a place to submit evidence. You also see your advisor's decisions, comments and the full activity history of every finding.

They are kept exactly as uploaded. Each file gets a SHA-256 fingerprint, so you can show that the document reviewed is the document you supplied, and duplicate uploads are flagged instead of reviewed twice.

No. Every upload, finding, evidence submission, revision request and approval is written to an activity history that can't be edited or deleted afterward. It's the record you show an auditor when they ask how a gap was closed.

Yes. The platform supports a multi-client portfolio, with each client's data kept separate from every other client's. Ask about it when you request an assessment.

Yes. The action plan exports to CSV, so your findings and their status can go into your own systems.

It reads your documents and drafts candidate gaps against the requirements in scope, with a pointer to the document and passage each one came from. That's a first pass. It doesn't decide anything: an advisor reviews every draft before it becomes a finding.

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.

Each client organization is isolated from every other, and files are held in private storage that is not publicly reachable. Your advisor and your own team see your data; other clients never do.

How your documents are processed, and by which providers, is set out in your engagement terms. Ask your advisor for the current position before you upload anything, and we'll answer in writing.

No. The request form only asks about your company, devices and timeline. Documents are uploaded after onboarding, into your own workspace.

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.

Usually, but not much. FDA generally pre-announces routine device inspections by phone, usually at least five calendar days ahead. For-cause inspections may come with no notice. Either way, the investigator presents a Form 482, Notice of Inspection, on arrival. Five days isn't enough to build readiness, which is why it has to be continuous rather than scheduled.

Yes. Under QMSR, internal audit, management review and supplier audit records are open to FDA inspection; the old exception that kept them out of view was removed. Write them knowing an investigator may read them.

A practice inspection run in the platform. Your advisor plays the investigator, issues document requests with response clocks, interviews your process owners and reveals practice observations at closeout. It is a rehearsal, never an FDA document.

They are FDA's inspection classifications: No Action Indicated, Voluntary Action Indicated and Official Action Indicated. The simulator ends with a simulated classification so your team can see where the exercise would have landed.

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.

Warning letters usually ask for a response within 15 business days of receipt. Read the letter itself for its exact request, and start the response the day it arrives.

For each observation: an honest acknowledgment, an investigation, a root cause, the correction and corrective action, a look at whether the problem exists elsewhere, evidence, and realistic dates. Promises without evidence or dates tend to read as unfinished.

Yes. Commitments in a response have to be delivered. Each one becomes a tracked item in your action plan with an owner, a date and the evidence your advisor needs to accept it.

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, and an advisor will set up a call to understand your situation. After that, you get a proposed scope, and once you agree, we set up your workspace and secure upload.

It depends on how many documents you have and how quickly your team can answer questions. Your advisor will give you a timeline as part of the scope, and the action plan shows progress as it happens.

Tell us the date when you request an assessment. A short timeline changes what's worth doing first, and your advisor will focus the work on the areas most likely to matter.