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