Healthcare
Production of medical devices is a strictly regulated business. These products can be crucial in matters of life and death. In almost all countries, and for most medical products, there are requirements and standards to which manufacturers need to show compliance.
This white paper reviews some key aspects of safety and performance assessments of AI medical device software according to the existing regulation (EU) 2017/745 (MDR) ahead of the upcoming regulatory updates and standards publication.
Conditions and processes for certification
What does it mean for manufacturers?
