This on-demand webinar, hosted by Greenlight Guru, focuses on the critical process of creating your Design History File (DHF)/Technical File (TF) and Risk Management File (RMF) for both hardware and software medical devices.
This free session guides you through the steps for creating DHF/TF and RMF, highlighting the differences between hardware and software technical files and risk documentation, and sharing best practices for compliance.
Main points covered:
1. Key steps for creating your Technical File and/or Design History File.
2. Required quality records to complete during each development phase.
3. Differences between Technical File and Design History File and maintaining both.
4. Integrating your Risk Management File into your TF/DHF and using risk practices during development and testing.
5. Achieving compliance for both hardware and software technical files and risk documentation.
Target Audience:
• Regulatory Affairs Professionals & Management
• Quality Professionals and Management
• Medical Device Executives
• Product Development Professionals & Management
Access the printable slides for this presentation by visiting:
www.greenlight.guru/webinar/h...
Негізгі бет Ғылым және технология How to Create Your DHF/TF & RMF for a Hardware or Software Medical Device
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