The core activity of Auchli CT is to advise and support companies in the areas of Technical Development, Systems Engineering, Quality Assurance and Risk Management, particularly in the development and implementation of products and projects, with a focus on medical technology, medical devices and pharmaceutical products.
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Offering
Products & services
Industry:Technical Consulting & Engineering
✓ Offered10
Technical Development and Systems Engineering
Technical development, systems engineering and requirements engineering from the initial idea to production; including project support, implementation and problem solving.
Quality Assurance and Quality Management
Quality assurance and quality management for development and production projects; including alignment of requirements, documentation and support for critical projects.
Risk Management
Risk management for medical technology and technical products; including risk analyses, process assessment, document review and implementation of accompanying measures.
Training
Training in systems engineering, risk management, FMEA, functional safety, statistics, DoE and TRIZ; including training materials and support during implementation.
Regulatory Compliance for Medical Technology
Regulatory compliance according to IEC 60601-x and related standards; including gap analysis, task lists, justifications for the notified body and test laboratory, as well as technical safety.
Systems Engineering and Requirements Engineering for Medical Devices
Systems engineering and requirements engineering for medical devices; including system analyses, safety architectures, technical requirements, verification and traceability.
Safety Engineering
Safety engineering for medical devices; including safety architectures, safety requirements, functional safety and verification requirements for development, production, operation and service.
Technical Leadership for Development
Technical leadership for external development projects; including technical, budget and quality responsibility, human factors engineering, risk management and design transfer.
Sterilisation and Documentation Advisory
Sterilisation of endoscopes and related documentation remediation; including system analysis, normative alignment, minimal approval-relevant documentation and responsibilities.
Remediation for MDR Approvals
Remediation for MDR approvals; including master plan, reclassification, technical documentation, risk management, CAPA, PMS and clinical evaluation.
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