Medical Device Software. IEC 62304

“… Because of its complexity, the development process for software should be even more tightly controlled than hardware ...” (FDA Guidance on Software Validation)

Software in medical devices must be developed and validated in compliance with appropriate standards and guidelines (EN 62304, FDA Guidance).

ISO 13485 and 21 CFR 820 also demand that IT systems that are used for quality-critical processes are validated.


  • Medical devices that include software (as a component or accessory)
  • Software products that are themselves classified as a medical device
  • Software used in the manufacture or quality control of a medical product which plays a critical role (e.g. Process control system, CAQ, ERP, LIMS)

Our services include:

  • Implementation of methods for software development (EN 62304) and validation (GAMP5)
  • Execution of validation projects
  • Staff training on software validation
  • Validation of IT systems

The Capamed Advantage:

  • Your validation project runs smoothly and efficiently
  • Submission of your validation results to the FDA or Notified Body