Questions, answered plainly.

A readiness score against ISO 13485:2016 and the QMSR, broken down by clause. The Audit Defense Pack (PDF): an executive summary, each finding with the clause it fails and the record behind it, ranked actions with owners and due dates, and a list of what the records could not show. An audit checklist of what an auditor or investigator is likely to ask on each clause where your records fall short, plus the full ISO 13485 question set as a self-audit workbook. An evidence ZIP arranged by clause, with a file manifest. A registers workbook (XLSX). A quarterly business review for leadership. And a 60-minute walk-through call.

Both sample reports are free to download.

None of those. The pack helps you prepare. It is not certification, and it neither is nor replaces an FDA inspection, an MDSAP audit or a registrar audit. Certification comes only from an accredited certification body, and FDA inspections only from FDA.

No. It tells you your current position, what your evidence supports and which fixes come first. The decisions after that are yours.

Scoring is clause by clause against ISO 13485:2016 and against FDA’s Quality Management System Regulation (QMSR, 21 CFR Part 820). Since 2 February 2026 the QMSR has incorporated ISO 13485:2016 by reference, with added provisions of its own on records (820.35) and on labeling and packaging (820.45).

Where your records touch them, findings also refer to the rules your QMS must link into: medical device reporting (21 CFR 803), corrections and removals (806), UDI (830), and risk management under ISO 14971. MDSAP and EU MDR audits rest on ISO 13485 for the quality system, so the pack helps you prepare for those as well.

Working to some other standard? Tell us on the fit check, and we will say frankly whether the pack would help.

AI assists the analysis. Each figure traces back to your own records, and the platform holds back anything the records cannot support. A person reads every page before it reaches you, and no compliance conclusion leaves us without that review.

No. We work from exports, install nothing, and connect to none of your systems.

Neither. It is not a medical device, takes no clinical decisions, and has no FDA clearance or approval. Nor is it your system of record: your QMS keeps that role, with its Part 11 controls. The pack is a readiness report made from copies of your records.

The exports you already produce, pasted into our Excel templates. The core seven are the CAPA log, nonconformances (NCR log), calibration list, training matrix, supplier list, document register and audit findings.

Further templates cover the other records an auditor asks for, among them risk, complaints, design controls, process validation, traceability and supplier receipts. Each extra register widens what the pack can assess, and the pack lists anything it could not assess, with the reason.

Yes. Paste values only (Home > Paste > Values) so that none of the source formatting comes across, then correct whatever the colours highlight. Line up your columns with ours by heading, not by position. Where you lack a value, leave the cell empty rather than guessing.

Locked sheets mean every file is read in exactly one way, which is how the pack can come back within five business days of complete data. Please leave the columns as they are: no renaming, moving, adding or deleting. Other formats, your own CSVs for example, need our agreement first and take longer.

Patient-identifiable information. Before upload, de-identify complaint, adverse-event and MDR records by removing patient names, dates of birth, medical record numbers, addresses and contact details. MedAssure is not built as a HIPAA-covered system.

Export-controlled technical data is also excluded, as is any personal data other than names, employee IDs and roles. Unsure about a record? Ask us before you upload it.

Every template has room for 1,000 records with its row checks in place (5,000 for supplier receipts), and there are 34 templates in all. A single file may be up to 20 MB, and each upload accepts up to 40 files and 60 MB; use the same link again to send more.

If a register is longer than its template allows, let us know before uploading.

With the private upload link the founder emails you. Email attachments are not the way to send them.

Processing happens on an encrypted workstation and through our AI provider, Anthropic, which does not train its models on our clients' data. Every customer's data goes into a store of its own.

The detail is on our data handling page.

Two parties: the person who checks your files and reviews each page of your pack, and Anthropic as processor for the analysis. Nobody else receives it. If you involve your quality consultant, they see only what you decide to share.

We delete it 30 days after the pack is delivered, unless you convert to a subscription. Ask and we delete it sooner. Either way we confirm the deletion in writing.

Not online. Take the fit check, which needs about two minutes. Submitting it emails your answers to the founder, who reviews them personally and confirms fit by email. The founder then emails you the Services Agreement, the Excel templates and an invoice.

You sign, pay the invoice, fill the templates from your exports (2–4 hours) and return them. We check the data and build the pack, and a person reviews it; it is ready within five business days of complete, accepted data. A 60-minute review call takes you through it.

Five business days, counted from the day your data is complete and accepted. That day we email you either an acceptance or a list of what is missing. Payment does not start the clock; complete data does.

Roughly 2–4 hours to fill the templates from your exports, then the one-hour walk-through call. If you would like help getting going, there is an optional 15-minute intake call.

List price for one facility is $12,500. The first five facilities pay the $7,500 founding price, by invoice once the founder has confirmed fit. There is no implementation fee, and nothing is paid online.

The pricing page lists what is and is not covered.

Miss the five business days for a reason we control, and we refund the whole fee.

The fit check is there so you learn before paying whether the pack suits your facility. Full terms are in the Audit Defense Pack Services Agreement, which the founder emails with the invoice and which you sign before paying.

A short interview about a week after delivery, a 15-minute call at day 30, and candid answers. A testimonial is your choice, only if you are pleased, and only in words you have approved.

Nothing more, unless you ask. To keep the pack current with a monthly refresh, a quarterly review and action tracking, the Founding Facility subscription costs $18,000 a year for the first 25 subscribers, held for three years (list $30,000). Sign within 30 days of delivery and the pack fee is credited.

Small and mid-sized medical device manufacturers (Class I to III, about 20 to 500 people), plus their contract manufacturers and their component and process suppliers: implants, instruments, sterile barrier packaging, contract sterilization, molding and machining. It suits you best when an FDA inspection, an ISO 13485 certification or surveillance audit, an MDSAP or notified-body audit, or QMSR rework is ahead, and your evidence is split between spreadsheets, the ERP, email and a QMS that nobody quite trusts.

Yes. Independent ISO 13485 and regulatory consultants can buy the pack on a client's behalf. It is built from that client's records, one facility per pack, and the client's data is handled under the same rules as everyone's. Pick “consultant” on the fit check and tell us about the client.

No. Most packs are bought by the manufacturer's own quality, regulatory or operations lead, and on the walk-through call we take you through the findings and the ranked actions ourselves.

Sometimes, for instance while you rework procedures and records for the QMSR. Still, the pack earns most with a date in view, because it ranks what to fix first. FDA often gives only a few days' notice of an inspection, so a baseline you could face an investigator with is worth having in itself. If waiting makes more sense, the fit check will say so.