• Is your device controlled by software?
  • Concerned about documenting software design, development and validation?
  • Does your software risk analysis support the device safety and performance claims?
  • Does your quality system include appropriate software-related procedures?

GEMAR can provide specialized computer system validation and compliance services, including evaluation of the existing documentation and advice on any actions that may be needed to comply with European and US requirements.
Feel free to contact us and see how we can assist you.