Focused on Safety from Concept to Product

"As an ISO 13485 certified company, we support you with software and system development from innovation consulting, prototypes and series development to product maintenance." 

System Development According to Standards

Support from idea to product and beyond – we develop for you, throughout the entire product life cycle, safety-critical software and systems in accordance with DIN EN 60601-1. Whether for approval by MDD, FDA and SFDA – with complete traceability and consistent documentation, we ensure that you can bring your product to market smoothly.

Realize Innovations Quickly

Quickly reaching the market with product innovation - whether as an Embedded Real-Time System or Desktop, Web or Mobile Application - is your key competitive advantage. Therefore, a top priority for us is on-time delivery and the correct implementation of the statutory requirements. We implement, if desired, future-proof platform concepts. Because they make implementing new products, within product families, faster and reduce development and material costs at the same time.

Our Services

System development (PEMS) according to DIN EN 60601-1

  • Concept Development and Feasibility Studies
  • Requirements Management / Requirements Engineering
  • Risk Management in Accordance with ISO 14971 / ISO 62304
  • Implementation of Usability of IEC 62366
  • Software Architecture, Software Design and Development
  • Simulation and Modeling (Virtual Prototyping)
  • Creation of Prototypes/ Mock-Ups
  • Static/Dynamic Code Analysis, Code-Coverage
  • Test Management and Test Automation
  • Verification and Validation
  • Product Maintenance
  • Real-Time Operating Systems (QNX, Linux, VxWorks, Keil RTX, FreeRTOS, ThreadX, Windows Embedded)
  • Software Development in Accordance with IEC 62304
  • Software Engineering
  • Embedded Systems
  • Algorithm Development (Image and Signal Processing, Control Systems)

Software Development according to IEC 62304

Consulting

  • Innovation Consulting
  • Tool and Process Consulting
  • Software Validation (SOUP, Tools, GAMP 5)
  • ALM (Application Lifecycle Management) & Documentation

    Product Maintenance

    • Software Updates
    • Analysis and Revision of Existing Legacy Systems
    • Maintenance and Support

    Applications

    • Assistance Systems  

      • Endoscope Guidance Systems
      • Navigation Systems

    • Respirators
    • Radiation Equipment
    • Imaging Systems (X-Ray, Ultrasound, MRI)
    • Surgery Equipment 
    • Injectors
    • Dental Treatment Units
    • Disinfection and Sterilization Systems
    • Diagnostic Systems
    • Documentation Systems
    • Surgical Microscopes
    • Tele-Medicine

    Emotion-sensitive Assistance System for People Suffering from Affective Disorders or Dementia

    Together with six partners from the scientific and industrial communities we develop a customizable, cooperative assistance systems for people suffering from Affective Disorders or Dementia.

    For more information please read our press release.

     

    Secure Remote Diagnosis and Maintenance in Medical Devices

    You’d like to monitor and maintain your medical devices at any time and from anywhere but without integration additional hardware?

    > Learn more

    Brochure Medical Engineering
    User Story BLDC
    Quality Management