FAT/SAT & Commissioning Support for Swiss MedTech Manufacturing
Audit-ready FAT/SAT and commissioning support for cleanroom automation, test equipment, vision systems, and V&V automation. I translate URS and risk controls into clear acceptance criteria, run or witness tests with vendors, and keep deviations controlled. Based in Switzerland, available on-site across Switzerland and remote across Europe.
Talk to me: info@techkrates.com • +41 783 20 66 33
Start small
FAT/SAT Acceptance Pack (6–10 hours)
Short, focused scope to align acceptance criteria, data capture, and punch-list handling before a vendor FAT or on-site SAT.
- Acceptance criteria table with FAT/SAT split
- Checklist and data capture expectations
- Punch-list template and closure rules
Who it’s for
- MedTech manufacturing teams releasing new production equipment
- Supplier-built automation with critical quality or safety functions
- Cleanroom equipment, test systems, and vision inspection lines
- Engineering + QA teams needing objective acceptance evidence
- Programs with tight commissioning windows and vendor dependencies
Typical situations
- Vendor FAT plans are generic and do not map to URS or risk controls
- SAT is drifting into re-testing because FAT evidence is unclear
- Deviations and punch-list items are not controlled or closed cleanly
- Commissioning schedule is tight and utilities/integration risk is high
- QA needs traceable acceptance evidence aligned to ISO 13485
Deliverables
- Acceptance criteria derived from URS and risk controls (ISO 13485, ISO 14971)
- FAT/SAT protocols, test scripts, or witnessing plans
- Vendor coordination and clear ownership for test execution
- Deviation handling and punch-list control with closure evidence
- Commissioning checklist, configuration baseline, and utility verification
- QA-ready reports and an evidence package aligned to FDA/EU expectations
Related insights
- FAT vs SAT: Acceptance criteria that prevent surprises
- Qualification documentation gaps that delay equipment release
- IQ vs OQ in practice: What evidence counts
FAQ
How long do FAT/SAT and commissioning take?
Timing depends on vendor readiness, equipment complexity, and site constraints. A clear acceptance pack usually shortens FAT/SAT cycles and reduces re-testing.
Remote vs on-site — what do you recommend?
Planning, review, and criteria definition are effective remote. FAT witnessing and SAT/commissioning typically require on-site presence.
How do you handle deviations?
Each deviation is logged with impact, owner, and closure evidence. Clear retest triggers prevent scope drift.
What information do you need from us?
URS/requirements, risk assessments, vendor FAT plans, equipment specs, and target acceptance criteria.