BAYOOSOFT Themis

An introduction to technical documentation under MDR and IVDR. 
Includes requirements from the annexes as well as risk classifications for medical devices and IVDs.

Complete overview of the requirements of ISO 27001. 
Structured guide for information security management systems.

Complete overview of the requirements of ISO 9001. 
Guide for quality management systems and continuous improvement.

Complete overview of the requirements of ISO 13485. 
Specifically for quality management in medical technology.

Comprehensive risk management in accordance with ISO 14971. 
PHA, design, process, and system FMEA, including bidirectional links.

Centralized management of regulatory and technical requirements.
Includes MDR, IVDR, MDSAP, IEC 60601-1, and Machinery Directive, along with traceability.

The complete solution BAYOOSOFT Themis
Includes all guides and packages for compliance, quality, and risk management.

Efficiently map integrated management systems. 
Particularly valuable when combined with one or more ISO Guides.