Fixed prices. Published before you book.
Every engagement starts with a written deliverable you can check. Prices below are proposals for the demo and will be confirmed before launch.
Roadmap Session
Your device's first case: a one-page standards matrix with a reason on every line.
Details →Test Strategy Package
The full case file you hand the lab: matrix, levels, criteria, plan.
Details →ISO 13485 & QMSR
Which requirements apply to your company, which don't, and why.
Details →Compliance kits
Applicability first, documents second. Templates you adapt.
Details →Case Keeper retainer
Your case kept current when the design, supplier or market changes.
Details →AI & cybersecurity
EU AI Act, FDA AI guidance and device cybersecurity. In development.
Details →| Service | Best for | What you get | Price |
|---|---|---|---|
| Free applicability sample | Anyone deciding what applies to them | 5–8 real requirements, each marked applies / doesn't apply, with the reason and clause | $0 |
| Roadmap Session | Engineers with a quote; one-person quality teams | 90 minutes on your device + a one-page matrix you keep | $450 |
| ISO 13485 Kit | One-person quality teams | Applicability list + templates to adapt + U.S. and EU notes + 12 months of updates | $697 |
| ISO 13485 Kit + Review | Teams who want a second pair of eyes | The kit + a 1-hour call + review of two completed documents | $1,297 |
| ISO 9001:2026 Kit | Non-device manufacturers | Applicability list and templates for the 2026 edition | $397 |
| Test Strategy Package: Core | Engineers at the test gate | The full device case file for one market route | $5,500 |
| Test Strategy Package: Full | Multi-market devices | Core + usability + particular standard + second route | $7,000 |
| ISO 13485 / QMSR gap assessment | Companies preparing for certification or FDA inspection | Written gap assessment, scoped per company | $3,500–$6,500 |
| Case Keeper retainer | After a delivered engagement | Your case kept current as the device changes | $2,500 / $4,500 per month |
Independent consultants in this field publish rates of $150 to $325 an hour. Our packages are fixed per tier and itemised, so you can check the hours yourself.
Start with your device's case.
A 90-minute Roadmap Session and a one-page standards matrix you keep, whatever you decide next.