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Computer System Validation in Medical Device

Medical device software validation is a process that is carried out to ensure the quality and reliability of an organization's product according to its intended use and in a justified and documented manner.

Ensure product quality and reliability

Software validation in healthcare products applies to:

  • Software used as a component, part or accessory of a medical device.
  • Software that is itself a medical device.

The regulation applies to the validation of software in medical devices is Regulation (EU) 2017/745, specifically in the 4th indent, b, section 6, Verification and Validation of Products.

At Oqotech we help validate computerized systems classified as medical devices, establishing an optimized work methodology based on the identification of risks of the computerized process.

Main activities

  • Computerized Systems Validation Strategy.
  • Validation of computerized systems.
  • Infrastructure qualification.
  • Maintenance of the control environment.


  • Compliance with regulations in a justified and documented manner.
  • Documented and controlled computerized process.
  • Service expected from suppliers in a detailed agreed and monitored manner.

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