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FREE ON-DEMAND WEBINAR
March 2, 2023
How to Create Your DHF/TF & RMF for a Hardware or Software Medical Device
Your Design History File (DHF) or Technical File (TF) is key in demonstrating your medical device was developed in compliance with regulations, applicable standards, and according to your project’s approved design plan.
One approach you can take actually allows you to create both your DHF/TF and your Risk Management File (RMF) in parallel.
This risk-based design approach can reduce the time and costs of repeated design iterations that may be required when risk is assessed late in the design process.
Register for this free webinar presented by Kyle Rose, President of Rook Quality Systems, who will provide a "how to" for DHF/TF and RMF creation for both SaMD and hardware devices.
We will expand on the key differences between hardware and software Technical File and Risk Documentation, and share best practices for efficiently achieving compliance for each.
Watch the webinar
Specifically, this webinar will help you:
- Identify the key steps to creating your Technical File and/or Design History File.
- Learn the quality records you are required to complete during each phase of development.
- Review the key differences between a Technical File and Design History File and best practices for maintaining both.
- Determine how your Risk Management File integrates into your TF/DHF and how to best use the risk practices during development and testing.
- Understand key differences between Hardware and Software Technical File and Risk Documentation and how to achieve compliance for each.
Who should attend?
- Regulatory Affairs Professionals & Management
- Quality Professionals and Management
- Medical Device Executives
- Clinical Affairs Professionals and Management
- Complaint and CAPA Management & Professionals
