Consulting for technical development, systems engineering, risk management and regulatory compliance from idea to production
Auchli CT – Consulting in Technology
Steffisburg (CH)New on Amplifa
About Auchli CT
Auchli CT is an independent technology consultancy run by Christian Auchli (Dipl. Physicist, Dipl. Electrical Engineer FH), based in Steffisburg, Switzerland. The company supports firms in technical development, systems and requirements engineering, quality assurance, risk management (FMEA), project management and the technical leadership of development projects – from the first idea to the industrialized product. A focus lies on regulated environments: safety engineering, regulatory compliance under IEC 60601-x, MDR and IVDR, human factors engineering, design transfer as well as sterilization and remediation documentation, in particular in medical technology, in pharmaceutical combination products and in general engineering. Methodologically, the work is based on systems engineering, DoE and statistics, the TRIZ innovation methodology, and IP/patent engineering. In addition, Auchli CT offers training in systems engineering, risk management, FMEA, functional safety, statistics and TRIZ.
- Site
- Steffisburg
- Processes
- Technical development and systems engineering, Quality assurance and risk management, Safety engineering (safety architectures) MDR, Systems and requirements engineering MDR/IVDR, Regulatory compliance (IEC 60601-x), MDR remediation (surgical instruments and accessories), Technical leadership of development of a combination product (autoinjector pen), Human factors engineering and design transfer
- Materials
- Systems Engineering, Risk Management / FMEA, DoE and Statistics, TRIZ Innovation Methodology, IP / Patent Engineering, Regulatory Compliance (IEC 60601-x, MDR, IVDR)
- Certificates
- Regulatory compliance (MDR/IVDR/IEC 60601-x)
- Founded
- 2004
- Industries
- Medical technology / Medical devices, Pharmaceutical industry / Combination products, Engineering / General industry
- 01
Technology assessment
- 02
Preliminary studies and feasibility
- 03
Development
- 04
Industrialization
- 05
Quality assurance and regulatory compliance
Methods and Tools
Systems Engineering
Problem-solving methodology for complex systems, applied to all tasks.
Risk Management / FMEA
Focus of quality assurance activities in regulated environments.
DoE and Statistics
Statistical design of experiments for cost reduction and robust prediction.
TRIZ Innovation Methodology
Systematic identification of innovative ideas and problem solutions.
IP / Patent Engineering
Assessment of patentability, freedom to operate and infringement, incl. research.
Regulatory Compliance (IEC 60601-x, MDR, IVDR)
Coverage of regulatory requirements for medical devices and diagnostics.
Location
Steffisburg
CHBusiness address
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Technical development and systems engineeringEngineering | – | – | – | – | – |
| Quality assurance and risk managementTesting | – | – | – | – | – |
| Safety engineering (safety architectures) MDREngineering | – | – | – | – | – |
| Systems and requirements engineering MDR/IVDREngineering | – | – | – | – | – |
| Regulatory compliance (IEC 60601-x)Testing | – | – | – | – | – |
| MDR remediation (surgical instruments and accessories)Engineering | – | – | – | – | – |
| Technical leadership of development of a combination product (autoinjector pen)Engineering | – | – | – | – | – |
| Human factors engineering and design transferEngineering | – | – | – | – | – |
| Test engineering (V&V)Testing | – | – | – | – | – |
| FMEA, functional safety, statistics, DoE, TRIZ trainingEngineering | – | – | – | – | – |
| Physics-based technical consulting (mechatronics, mechanics, electronics)Engineering | – | – | – | – | – |
| IP engineering / patent engineeringEngineering | – | – | – | – | – |
Additional services
Quality and Compliance
The focus is on quality assurance and risk management methods as well as compliance with regulatory requirements (IEC 60601-x, MDR, IVDR) in regulated environments.
| Evidence | Steffisburg |
|---|---|
| Regulatory compliance (MDR/IVDR/IEC 60601-x) |
History
- 2004
Christian Auchli supports companies as an independent technology consultant.
- 2005
Establishment of Auchli CT; 2005–2025: 20 years of Auchli CT.