Case Study

Certifying Medical Image Correction Systems

Critical Software was tasked by a medical image-processing start-up to provide essential certification support, necessary for the classification of their image correction systems as a Class IIb medical device. 

We assisted the company in producing all the required artefacts as set out by European standards. Certification activities involved processes already in motion, meaning a more cautious approach to project management was needed in addition to our usual attention to detail to ensure evidences satisfied regulatory demands. 

In this case study, learn more about:

  • Class B software and what this entails, according to IEC 62304
  • The certification activities we performed on the system
  • The ISO and IEC standards required for certification
  • The role of our solution in helping our client develop their technical capabilities
  • The technologies used in this project
certifying medical image correction systems case study