Validation of regulated software

Software used in administrative and supporting tools by a Medical Device manufacturer that could affect the quality of the end-product or service need to be validated for its intended purpose. This includes software in design tools, complaint handling, document control etc.

We can support you with:

  • Validation risk assessment
  • Establishing or improving company procedures
  • Establishing and executing validation master plan
  • Incorporating procedures in overall QMS structure
  • Validation templates, protocols, reports etc
  • Validation project management support
  • Training

Contact me for further information
Robert Ginsberg
Office +46 8 621 01 05 or send me a mail