Medical Device Software

We have 20 years of Experience with Medical Device Software in all of its facets:

  • Software Safety and Cybersecurity

  • Artificial Intelligence

  • Data Protection

  • E2E Software Lifecycle Process (IEC 62304)

  • Computer System Validation (CSV)

  • Documentation and Submission of Medical Device Software

Software Safety and Cybersecurity, Artificial Intelligence – Preparation for Submission / Certification, Data Protection, Software Lifecycle Process, Software Risk Management, Documentation and Submission of Medical Device Software according to IEC 62304, ISO 14971, IEC 80001-X, IEC 80002-X, IEC 82304-X, AAMI TIR32, AAMI TIR57, GPSV, FDA Software and Cybersecurity Guidelines and General Data Protection Regulation (GDPR) for:

  • Software in a Medical Device

  • Software as a Medical Device (SaMD)

  • Software in a Combination Product

  • Mobile Medical Applications

  • (Medical) Clouds

  • Software used for In Vitro Diagnostics

  • Production Equipment

  • Hospital Information Systems

Medical Devices

Medical Device Software

In-Vitro Diagnostic Devices

Combination Products