Classification Document for Alfred Surgery©

1. Introduction 

  • Purpose: This document outlines the classification of AlfredSurgery© as non-medical software.
  • Scope: Applicable to all versions of AlfredSurgery©. 

2. Intended Use 

  • Description: AlfredSurgery© is designed for education, simulation and certification of health care personnel and as a tool for knowledge support.
  • Intended Users: Health care personnel, healthcare administrators. 

3. Regulatory Definitions 

  • Non-Medical Software: As per Medical Device Coordination Group 2019-11, nonmedical software is defined as software that does not diagnose, treat, mitigate, or prevent diseases or conditions. 

4. Functionality 

  • Core Functions:
    • Building educational protocols
    • Managing educational data from users
    • Digital tool for knowledge support
  • Excluded Functions:
    • No diagnostic or therapeutic capabilities
    • No direct patient interaction or data analysis 

5. Risk Assessment

  • Risk Level: Low
  • Justification: The software does not perform any medical functions or provide direct benefits to patients. 

6. Compliance with Standards 

  • General Software Standards: Compliance with Normen for information security management.
  • Data Protection: Adherence to GDPR for data privacy. 

7. Quality Management System (QMS) 

  • Overview: Description of the QMS in place to ensure software quality and security.
  • Processes: Development, testing, and maintenance procedures. 

8. Conclusion 

  • Classification: Based on the intended use and functionality AlfredSurgery© is classified as non-medical software.
  • Regulatory Implications: No need for medical device regulatory approval.