TechkratesFAT/SAT Acceptance Pack
Acceptance criteria split into FAT and SAT, a checklist and punch-list rules. One week, from CHF 1 500.
Criteria tableChecklistPunch list
FAT, SAT and commissioning for MedTech production equipment
Acceptance criteria from your URS and risk controls, FAT run or witnessed at the vendor, SAT and commissioning on site, deviations and punch list under control.
- FAT
- SAT
- Commissioning
- ISO 13485
- ISO 14971
- ISO 14644
Typical tasks
From acceptance criteria to equipment ready for IQ.
FAT at the vendor, run or witnessed
Protocols and test scripts, so the evidence carries over to SAT.
FAT protocolEvidence
SAT and commissioning on site
Utilities, configuration baseline and SAT, without re-testing what FAT proved.
SAT reportBaseline
Deviations and punch-list close-out
Each item with impact, owner and closure evidence, ready for IQ and OQ.
Deviation logClosure evidence
How we start
From the first call to the documents, in four steps.
Work starts within a week of the offer.
- 30 minutes
Scope call
The device, the task, the deadline and your quality system.
Call notes - Within 2 days
Fixed offer
Deliverables, price and dates on one page.
Offer · plan - Start within a week
Work
Design, build and test, with a short status every week.
Weekly status · reviews - At the end
Handover
Everything in your templates, ready for your DHF and your production.
Drawings · reports · files
Proof
FAT and SAT written and run for two cleanroom production machines, qualified from DQ to PQ within two months.
From our founder's track record, for a Swiss medical device manufacturer.
Standards we work with
- ISO 13485
- Acceptance evidence under the QMS
- ISO 14971
- Acceptance criteria from risk controls
- GAMP 5
- Where the equipment carries software
- ISO 14644
- Cleanroom installations
FAT proves the vendor build against the URS before shipment. SAT confirms the same criteria after installation; IQ and OQ build on that evidence.
FAQ
Questions we hear first.
How long do FAT, SAT and commissioning take?
It depends on vendor readiness and equipment complexity. A clear acceptance pack shortens both and avoids re-testing.
On site or remote?
Criteria and protocols are written remotely. FAT witnessing, SAT and commissioning are on site in Switzerland and Germany.
What do you need from us?
URS, risk assessment, the vendor's FAT plan, equipment specifications and your target acceptance criteria.
Do you sign an NDA, and who owns the results?
Yes. Techkrates signs your NDA before the first technical details, and the designs, documents and data made for your project belong to you.
In which language are the documents?
German or English, in your templates and your document numbering.
Send two or three lines about the device and what you need.
An engineer answers within 24 hours. At a fixed price per task or from CHF 950 per day.
- Company
- Techkrates, Zurich
- On site
- Switzerland and Germany
- Languages
- English, German
- Contact