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