The Device Case File.
Your device's case, on paper before you accept a test quote: what applies, what doesn't and why, the test levels, and what counts as a pass.
Your case. Your criteria. A reason for every line.
The lab still runs every test your case requires; the evaluator still decides. The case stays yours; you sign it. Offered after a Roadmap Session, so you've already seen the first page of your own matrix before you decide.
The lab quote (sample)
Your device's case
Every line gets a tag: required for your route or ask the lab why. Never "remove." Justified scope, not reduced scope.
Set by your inputs, not by what we find.
The tier is chosen from your markets and project scope at the end of the Roadmap Session, in writing, before the full matrix is written.
Core Case
- Device description and route note
- Standards matrix, a reason on every line, including those that don't apply
- Test levels, per test, with the source of each
- Draft pass/fail criteria for your signature
- Test plan the lab executes
- Pre-lab bench check
- Two revision rounds within 60 days
Full Case
- Everything in Core
- Usability (IEC 62366-1) worked out for your route
- Your particular standard (IEC 60601-2-xx) in full
- Second market route written as a delta per line
- Up to three quotes laid against the case
- 60-minute walk-through before you send it to the lab
Your Roadmap Session fee comes off either tier. Estimated work: about 43–46 hours for Core, itemised in your proposal so you can check the arithmetic.
The pieces that make the case usable.
Quote-against-case sheet
Every line on your quotes: required for your route, or ask the lab why. For comparing quotes, never for a lower total.
Lab question letter
The questions to send every lab, so answers are in writing before the chamber is booked.
Design-change map
Which design changes would reopen which lines: power supply, enclosure, new market.
One-page approval sheet
What the case covers, the fee, the schedule and what it does not promise, for your CEO or board.
Read the full matrix first. Stop there if you want.
The complete standards matrix is delivered first. If you stop after reading it, you keep it and pay only for that stage.
What you don't get
- A promise the quote falls. It may go up if your case finds a line nobody listed.
- A promise of a pass, clearance, certification or zero findings.
- Any required test skipped. Justified scope, not reduced scope.
About the package.
Do you run the tests?
No. We're not a test lab, certification body or notified body. You hand the lab your plan; the lab runs every test your case requires.
Which standards does this cover?
IEC 60601-1 and IEC 60601-1-2 (EMC) with the collaterals that apply to your device in Core; usability, your particular standard and a second route in Full.
What if the lab disagrees with a line?
Every line has a written reason. We answer the lab's questions in writing during your revision rounds.
Start with your device's case.
A 90-minute Roadmap Session and a one-page standards matrix you keep, whatever you decide next.