Can I read Steps for DiGA Directory Compliance on EtoBox?

Steps for DiGA Directory Compliance by Regulatonomous Open is a document available to read on EtoBox.

What is Steps for DiGA Directory Compliance about?

This document outlines the 7 key steps required for manufacturers to list their Digital Health Applications (DiGA) in the DiGA directory in Germany: 1. Define the business case and intended purpose of the DiGA. 2. Identify applicable regulatory requirements for medical devices and DiGAs. 3. Determine evaluation concepts and clinical study strategies to prove health benefits. 4. Establish an integrated quality and IT security management system. 5. Create technical documentation about the product. 6. Cond

Author

Regulatonomous Open

Language

EN