Your device's case, on paper before you sign the test quote.
What applies, what doesn't and why, the test levels, and what counts as a pass. Written down first, so the lab runs your plan instead of writing it for you.
The lab still runs every test your case requires. The evaluator still decides. The case stays yours.
See how it worksA test quote is a scope somebody else wrote.
Most device teams ask the lab what to test. It's a reasonable question. But labs quote what they're asked to quote, and certification bodies aren't allowed to consult on your design. So the scope gets set before anyone has written down what your device actually is.
That's how teams end up with lines they can't explain, tests that come back asking for more, and pass/fail criteria nobody agreed on beforehand.
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.
Two starting points.
Most clients arrive holding a lab quote, or holding an ISO 13485 project they're running alone.
The engineer at the test gate
- An IEC 60601 safety, EMC or usability quote on your desk
- Lines you can't explain, or two quotes that don't match
- A design that's still moving, and a date that isn't
The one-person quality team
- ISO 13485 and FDA's QMSR, with no one to check your calls
- Templates that don't say which requirements apply to you
- A CEO who wants to know why it costs what it costs
Three steps. You can stop after any of them.
Roadmap Session
90 minutes on your device. A few days later you get a one-page standards matrix with a reason on every line. It's yours to keep.
Your device's case
The full case file: every standard and collateral, test levels with their sources, draft pass/fail criteria for your signature, and the test plan.
The lab executes
You hand the lab your plan. Every line on the quote is either required for your route or a question you've already asked in writing.
Notice what's missing from our terms.
A pass. A clearance. A smaller quote. Nobody can promise the evaluator's verdict before the tests have run, so we don't. We put money behind the work.
What we stand behind
- A written reason on every line of your matrix
- Delivery on the date we agree
- Your Roadmap Session fee back if the read-out isn't worth it, and you keep the read-out
- The session fee credited in full toward the case
What we never promise
- FDA clearance, certification or a notified-body outcome
- Passing first time, or "no findings"
- A lower test quote. Your quote may go up if your case finds a line nobody listed
- Skipping any test your device requires
Start small. Every step proves itself before the next.
Do you have a case, or only a quote?
Five questions. Honest answer at the end.
1. Do you have a written device description an evaluator would recognise?
2. Could you give a written reason for every standard on your quote?
3. Who wrote your EMC pass/fail criteria?
4. Have you decided report-only vs. a certification mark?
Reading for the week before the quote.
Your test quote is a scope somebody else wrote
Why the order of events matters more than the price on the page.
Read →Who writes your pass/fail criteria?
The line in your EMC plan most teams discover after testing.
Coming soon →“Doesn’t apply” needs a reason too
How to record the standards you're not testing to, and why auditors ask.
Coming soon →More ways in.
Start with your device's case.
A 90-minute Roadmap Session and a one-page standards matrix you keep, whatever you decide next.