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