Stratipath’s solutions & platform

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.

Regulatory and compliance

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 (L√§kemedelsverket)

  • 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