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With more than 20 years’ experience in medical device software development, verification and validation we support you with our experienced team for compliance of your active medical devices which are driven by a software or are a standalone software.

Software Validation - Embedded Software Development and Testing for Medical Devices

The main services we provide :

  • Definition of SW & HW Requirements according to your intended purpose and related engineering activities,
  • Hardware design and development (PCB, Analog, Digital)
  • Algorithm development
  • Software architecture, design and development in accordance with IEC 62304
  • Independent verification and validation according to US FDA requirements
  • Risk management in accordance with ISO 14971 and IEC/EN 62304
  • Implementation of usability engineering in accordance with IEC/EN 62366
  • Preparation of complete design history file (DHF) and technical documentation according to the state of art standards and regulations such as ISO 13485, US CFR §820.30, EU MDR 2017/745, IVDR 2017/746
  • SW maintenance
  • Mobile App development according to US FDA requirements

How can we help you?

If you need more information, we will be glad to have a chat