Many medical devices contain software components or parts which monitor or control the system, such as
  • Firmware or other software-based control

  • Stand-alone software applications

  • Device-related software for installation in other computers

  • Dedicated hardware/software for medical devices

  • Accessories to medical devices


The medical device then becomes a ‘software device’ and special documentation is required to achieve compliance with current regulations, including preparation of 510(k) submissions.
GEMARMED specialists in software validation can help you in preparing this documentation, including
  • Level of concern of the software device

  • Required documents according to level of concern

  • Software description

  • Hazard analysis & risk assessment

  • Software requirements
  • Architecture design
  • Software design
  • Traceability
  • Development environment
  • Verification & validation
  • Management of anomalies
Contact our staff, who will be pleased to help you to in review or preparation of this documentation to appropriate quality standards and guidance documents.