Engineering services for MedTech manufacturing in Switzerland
Engineering-first support for regulated MedTech manufacturing: hands-on mechanical, mechatronics, and embedded work with evidence-aware execution.
When a line is unstable, a retrofit is forced, or a test rig is missing, I focus on root cause, the fix, and verification evidence so QA can release changes without delay.
Talk to me: info@techkrates.com • +41 783 20 66 33
Engineering problems I solve
Field issue / retrofit sprint
- Root-cause analysis under time pressure
- Retrofit fix with verification evidence (issue → fix → release)
Sensors & measurement integration
- Flow/pressure/temperature sensing with calibration logic
- Failure modes, drift checks, and redundancy behavior
Test stands/fixtures & GR&R/MSA
- Repeatability and stability of fixtures and test methods
- Evidence capture with logging and configuration IDs
Mechatronics prototyping
- Arduino/STM32, motors, pneumatics, safety interlocks
- Rapid prototypes with controlled IO and logging
Manufacturing equipment stabilization
- Scrap/downtime reduction and intermittent fault isolation
- Process tuning tied to a defensible evidence trail
Change impact for embedded/software in regulated context (IEC 62304-aware)
- Impact assessment and evidence mapping for changes
- Controlled change summary and re-verification scope
Typical deliverables
- Requirements and acceptance criteria
- Architecture outline and interfaces
- BOM, wiring, and integration notes
- Prototype build and iteration log
- Test method with pass/fail logic
- Verification notes and evidence summary
- Change summary for QA and engineering release
How I keep it audit-safe without slowing engineering
Traceability lite (requirements → tests), lightweight evidence capture during builds, and tight change control keep work audit-ready without documentation drag.
Related projects and insights
- Field retrofit sprint case snapshot
- Connected device add-on: CSV → CSA project
- Airflow safety system case (Omron D6F)
- Test stands repeatability: GR&R and MSA
- Windows CE to Windows 10 IoT migration (IEC 62304)
Related services
- Equipment qualification (DQ/IQ/OQ/PQ) + FAT/SAT
- CSV/CSA for product and manufacturing support systems
- Test stands & fixtures for verification & manufacturing
FAQ
How fast can a retrofit sprint start?
After a short scope call and access to logs/schematics, I can start with a focused on-site or remote diagnosis and a concrete retrofit plan.
Do you work on-site in Swiss manufacturing environments?
Yes — on-site for troubleshooting and build work, with remote follow-up for analysis, documentation, and evidence packaging.
How do you keep documentation lightweight but audit-ready?
I capture evidence as part of the build/test flow and keep traceability tight to only the impacted requirements.
Can you align changes with IEC 62304 expectations?
Yes — change impact is mapped to evidence deltas and a controlled re-verification scope.