How it works
Files from you. A reviewed pack from us.
You install nothing, log in nowhere and change nothing in your QMS, and nothing is paid online. Below is each step and who owns it.
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Take the fit check · you, about 2 minutes online
Twelve questions cover your role, ISO 13485 and FDA status, device class, next inspection or audit, the records you can export, and whether any of them hold patient-identifiable or export-controlled data. You learn whether the beta suits your facility before paying anything.
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The founder reviews your answers · by email
Submitting the check emails your answers to the founder. Every answer is read personally, and the founder writes back to confirm that the Pack fits, or to raise what needs settling first.
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Agreement, templates and invoice · from the founder, by email
Once fit is confirmed, the founder emails you the Audit Defense Pack Services Agreement, the Excel templates with their guide, and an invoice for the $7,500 founding price. There is no online payment: every engagement goes through the founder.
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Sign, pay and fill the templates · you, about 2–4 hours
Sign the agreement and pay the invoice. Then paste in the exports you already run: the sheets highlight gaps and wrong formats so you can correct them first. Leave the formatting alone, take patient details out of complaint records, and return the files through the private upload link we email you.
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Data check, pack and review · us, within five business days of complete, accepted data
A person looks at every file before anything is loaded, and you get either an acceptance email or a precise list of what is missing. The five business days run from that acceptance.
The platform scores readiness against ISO 13485:2016 and the QMSR, links each finding to its clause and its record, and ranks the actions. A quality professional then reads each page before release.
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Review call · together, 60 minutes
When the pack is ready we send a link to book the call, and the files arrive as it starts. We take you through your position, what the evidence supports, and which fixes come first.
What you send
At minimum, these templates:
- CAPA log
- Nonconformances (NCR log)
- Calibration list
- Training matrix
- Supplier list
- Document register
- Audit findings
Complaint, design history, risk and validation records add depth, and each has its own template. Anything the pack could not assess for lack of records, it names.
What we cannot accept
Patient-identifiable information: de-identify complaint and adverse-event records before you upload. We also take no export-controlled technical data, and no personal data beyond names, employee IDs and roles. Unsure about a record? Ask us first.
Where a person steps in
- Reads your fit check answers and confirms fit
- Checks the data before the five days begin
- Reads every page before it reaches you
- Leads your review call
Every compliance conclusion passes human review before it is issued.