Custom Development
Project Management
- Project management with focus on timelines, costs and quality targets
- Preparation of project plans based on QM phases and technical integration points
- Resource and budget planning for development and internal and external verification
- Documentation of project progress and communication
- Compliance with regulatory requirements
Systems Engineering
- Architectures for measuring systems and medical products / systems
- Selection and evaluation of parts and components
- Cost-controlled bills of materials
- Implementation of regulatory requirements into system design
- Implementation of customer requirements into system design
- Development of functional prototypes for early qualification
- Preliminary tests with in-house test systems and in external laboratories
- Step-by-step documentation of integration levels
- Creation of system FMEAs for integration into risk management
Electronic Design
- Schematic design according to regulatory and customer-specific requirements
- EMC-compliant PCB layout
- Module simulation
- PCB design from functional models to serial production
- Design of analog electronics
- Integration of special modules (e.g. motor controllers or Field Programmable Gate Arrays / FPGAs)
- Security-optimized μController architectures
- BUS systems and interfaces
Mechanical Construction
- Mechanical design of sensor components and assemblies
- Implementation of regulatory requirements (fire protection, stability, IP requirements)
- Implementation of industrial design
- Close cooperation with industrial designers regarding mechanical and electronic realization of enclosures
- Optimization of mechanical designs for tooling (e.g. injection molding, bending)
Software Lifecycle
- Use of our field-tested em-frame for rapid realization of transparent data models even beyond system boundaries
- Mapping of a complete IEC 62304- and FDA-compliant software lifecycle
- Embedded software on RTOS architectures
- Windows software
- Complex software integration tests with our flexible test suite
- Multiprocessor and safety systems
- Software classes A-C
Verification & Validation
- Verification of system requirements
- Complete traceability within a design control environment (V-model)
- Support for Usability Validations (plan, questionnaires)
- Validation of systems and processes
Quality Management
- Optimization and modification of your QM system towards ISO 13485 / FDA 21 CFR Part 820
- Consulting and support for risk management according to ISO 14971
- Consulting for the development of active medical devices within the framework of the 60601-1
- Strategy consulting relating to regulatory approaches (Regulatory Affairs) for worldwide approvals
- Creation of clinical evaluations
- Implementation of IEC 62304 and FDA-compliant software development
- Consulting for the establishment of regulatory-proof QM standards operating procedures and work instructions
- Audit support e.g. for OEM projects
Production Transfer and Serial Custom Production
- Transfer of successful development projects into in-house contract manufacture
- Production of components, assemblies or complete devices in small, medium or large quantities
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