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Medical technology

Our development service for your medical technology product starts with the consulting for standards as well statutory regulations, and moves through all the phases of the development: From the development planning to the risk management and certification of the finished products. Particular attention will be paid to the documentation of development in accordance with legal requirements by the MPG and the applicable standards (e.g. DIN EN 62304). In consideration of special requirements concerning of this market, we provide certified services for your medical technology product in the areas of development, production and service.

Development

  • certified quality management according ISO 13485
  • design of analogue and digital interfaces for the measurement readings, measured value processing and providing for higher-level-systems
  • developing devices in accordance with the standards series DIN EN 60601
  • Design Embedded Systems
  • FPGA-Design
  • creating Firmware for a wide range of controller families
  • developing of medical applications software for Windows, OS X, iOS und Android
  • implemented Software Lifecycle Process according DIN EN 62304
  • house-made consruction of prototypes and samples

Production

  • certified production according ISO 13485
  • traceability by coupled ERP-Tracability-System
  • completely lead-free production
  • separately management of additional components

Service

  • certified repair services according ISO 13485
  • spare parts procurement
  • delivery directly to the end customer is possible
  • individual consignment stocks
  • After Sales Service

Participated in following products