Pricing
One facility, one price, nothing hidden.
The list price is $12,500. The first five facilities pay $7,500 and give us candid feedback on the report in return. There is no implementation fee.
Per facility, paid by invoice. Take up a Founding Facility subscription within 30 days of delivery and the full fee is credited.
- A readiness score against ISO 13485:2016 and the QMSR, broken down by clause
- The Audit Defense Pack (PDF): executive summary, each finding with its clause and source record, ranked actions with owners and due dates, and what the records could not show
- Your audit checklist: 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
- A 60-minute walk-through call
- An optional 15-minute intake call
Nothing is paid online. The invoice comes from the founder, after the fit check and once fit is confirmed.
How you buy it
- Fit check. About two minutes online.
- The founder reviews your answers. Submitting the check emails them to the founder, who reads them personally and confirms fit by email.
- Agreement, templates and invoice. Once fit is confirmed, the founder emails the Services Agreement, the Excel templates and an invoice. There is no online payment.
- Your part. Sign, pay the invoice, fill the templates from your exports (2–4 hours) and return them.
- Ours. We check the data and build the pack, and a person reviews it. Your pack follows within five business days once the data is complete and accepted.
- Review call. 60 minutes, together.
Not included
- Certification, an FDA inspection, a registrar audit, or a promised audit or inspection result
- Regulatory submissions, or clinical, safety or reportability decisions taken on your behalf
- Patient-identifiable information (de-identify complaint records first) and export-controlled technical data
- Software, logins or links into your systems. Files travel each way, and that is all.
- A second facility in the same pack
- Updating the pack after delivery, which is what the subscription below is for
What the founding price asks of you
- A short interview about a week after delivery
- A 15-minute call at day 30
- Candid answers
A testimonial is your choice, only if you are pleased, and only in words you have approved.
Late means refunded
The pack is ready within five business days of the day your data is complete and accepted. Miss that for a reason we control, and we refund the whole fee.
After the pack
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.
Packs 6 to 15 cost $10,000, and Pack 16 onward costs $12,500. Groups of two or more sites pay $50,000 a year per site.
If we quoted you the earlier founding-beta price in writing before 1 October 2026, that price stands.