Medical devices incorporating a software require formal software validation

The required validation documentation depends on the level of concern (=criticality) of the software.

We help you in: 

• Evaluating the level of concern linked with your product 
• Safely designing the software architecture
• Conducting risk management activities
• Planning software verification and validation
• Fullfilling IEC 62304 requirements (software lifecycle processes)
• Integrating, if necessary, ISO/IEC 15504 (SPICE)
• Reviewing code and documentation
• Integrating the documentation in the regulatory technical file