Engineering for medical technology products and manufacturing: development, verification, equipment qualification DQ/IQ/OQ/PQ and CSV/CSA.
Techkrates
Zurich (Switzerland)New on Amplifa
About Techkrates
Techkrates is an engineering company based in Zurich that develops mechanical and electronic systems for medical devices, test equipment and manufacturing systems. The services include product development with mechanical design (3D CAD, tolerance analysis, prototypes), electronics and PCB development, embedded firmware as well as verification and validation with test benches, fixtures and GR&R/MSA. A key focus is equipment and process qualification (DQ/IQ/OQ/PQ) with FAT/SAT acceptance, deviation log and QA-compliant documentation packages for regulated manufacturing, in particular cleanroom environments. In addition, risk-based CSV/CSA for software and connected systems, industrialization, production transfer, manufacturing engineering and retrofit are offered. The work follows standards such as ISO 13485, ISO 14971, IEC 60601, IEC 62304 and GAMP 5; specialist partners come in for PLC integration and manufacturing. Customers come from medical technology, biotech, pharma, special machinery, laboratory and analytical instruments, optics, photonics as well as sensor technology and metrology.
- Site
- Zurich, Switzerland
- Processes
- Product development: mechanics, electronics, firmware, Mechanical design and CAD (3D CAD, drawings, tolerance analysis), Prototype build (mechatronics, Arduino/STM32, motors, pneumatics), Circuit and PCB design, embedded firmware, Equipment qualification (DQ/IQ/OQ/PQ) + FAT/SAT, Test benches, test fixtures and test automation (jigs, gauges, data logging, GR&R/MSA), Verification and validation (V&V), test planning and test execution, CSV/CSA Computer System Validation
- Materials
- Mechanical Design and CAD, Electronics and PCB Development, Test Benches and Test Fixtures, Equipment Qualification DQ/IQ/OQ/PQ + FAT/SAT, CSV/CSA Computer System Validation, Control Engineering and Automation
- Certificates
- ISO 13485 (standards environment), ISO 14971 (standards environment), IEC 60601 (standards environment), IEC 62304 (standards environment), GAMP 5
- Industries
- Medical Technology, Biotech, Pharmaceuticals, Special Machinery and Automation, Laboratory and Analytical Instruments, Optics and Photonics
- 01
Clarify requirements and acceptance criteria
- 02
Planning and risk-based scope
- 03
Design: mechanics, electronics, firmware
- 04
Prototype build and verification
- 05
Equipment qualification DQ/IQ/OQ/PQ or FAT/SAT
- 06
Handover with QA-compliant documentation package
Processes and Standards
Mechanical Design and CAD
3D CAD, drawings and tolerance analysis for machine elements, assemblies and devices, designed for function and manufacturability.
Electronics and PCB Development
Circuit and PCB design, embedded firmware and EMC pre-compliance, led by Patrick Keller with over ten years of medical technology electronics.
Test Benches and Test Fixtures
Mechatronic test solutions with sensors, motion, data logging and embedded control for verification and end-of-line testing.
Equipment Qualification DQ/IQ/OQ/PQ + FAT/SAT
Risk-based qualification of production equipment with protocols, execution support and audit-ready documentation.
CSV/CSA Computer System Validation
Risk-based validation of software and connected systems according to intended use, criticality and data integrity.
Control Engineering and Automation
PLC integration and safety functions per ISO 13849-1 and IEC 60204-1, partly via partner network.
Locations
Zurich
CHHeadquarters / Engineering
Service Areas
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Product development: mechanics, electronics, firmwareEngineering | – | – | – | – | – |
| Mechanical design and CAD (3D CAD, drawings, tolerance analysis)Engineering | – | – | – | – | – |
| Prototype build (mechatronics, Arduino/STM32, motors, pneumatics)Engineering | – | – | – | – | – |
| Circuit and PCB design, embedded firmwareEngineering | – | – | – | – | – |
| Equipment qualification (DQ/IQ/OQ/PQ) + FAT/SATTesting | – | – | – | – | – |
| Test benches, test fixtures and test automation (jigs, gauges, data logging, GR&R/MSA)Testing | – | – | – | – | – |
| Verification and validation (V&V), test planning and test executionTesting | – | – | – | – | – |
| CSV/CSA Computer System ValidationEngineering | – | – | – | – | – |
| Industrialization and production transferEngineering | – | – | – | – | – |
| Manufacturing engineering, retrofit and equipment stabilizationEngineering | – | – | – | – | – |
| Sensor and measurement system integration (flow/pressure/temperature, calibration logic)Engineering | – | – | – | – | – |
| PLC integration and control engineering (safety functions per ISO 13849-1, IEC 60204-1)Engineering | – | – | – | – | – |
Additional services
Reference customers
Quality and Standards
The work is oriented to ISO 13485, ISO 14971, FDA 21 CFR 820 (QMSR), IEC 60601, IEC 62304, ISO 10993, GAMP 5 and ISO 14644; certification testing is performed by accredited testing laboratories, for which Techkrates prepares design, test evidence and documentation. Measuring instruments and test methods are safeguarded with GR&R/MSA and traceable calibration logic.
| Evidence | Zurich |
|---|---|
| ISO 13485 (standards environment) | |
| ISO 14971 (standards environment) | |
| IEC 60601 (standards environment) | |
| IEC 62304 (standards environment) | |
| GAMP 5 |