In parallel with the development of Stratipath Breast, Stratipath’s scalable AI platform was also developed in order to rapidly create new data-based solutions for the healthcare and life science industry.
At Stratipath, we believe in combining clinical knowledge, research, and cutting-edge AI capabilities to create solutions that will benefit patient outcomes.
In parallel with the development of Stratipath Breast, Stratipath’s scalable AI platform was also developed in order to rapidly create new data-based solutions for the healthcare and life science industry.
At Stratipath, we believe in combining clinical knowledge, research, and cutting-edge AI capabilities to create solutions that will benefit patient outcomes.
High requirements for precision and security for medical devices intended for use in clinical diagnostics
The manufacturer's affirmation that products meet all the requirements applicable in relevant EU directives/regulations
Free movement on markets within the EU and EEA
Registered at competent authority (Läkemedelsverket)
CE marking required for in vitro diagnostic (IVD) medical devices to be placed on the market
What does this mean for Stratipath?
Documentation and quality assurance of the product life cycle
Rigorous and structured verification and validation
Surveillance of all systems during use
Documented work processes and education of personnel
Responsibility for provable marketing