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

RQS-GG-Webinar 3-2-23
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 
Register Now  

Hosted by

Etienne Nichols

Medical Device Guru and Community Manager,
Greenlight Guru

Kyle Rose headshot-round
Kyle Rose

Rook Quality Systems


About Greenlight Guru

Greenlight Guru is the leading cloud-based platform purpose-built for MedTech companies. The end-to-end solution goes beyond traditional QMS needs by integrating cross-functional teams, processes, and data throughout the entire product lifecycle so device makers can proactively overcome execution gaps, streamline compliance, and accelerate market success. Greenlight Guru’s platform is used by organizations across the globe that are replacing their disjointed, legacy tools and solutions to bring life-changing products to people faster, and with less risk. Visit our homepage to learn more.

Rook-Logo-03-23-22-blue-01 - Patrick Sherman

Rook Quality Systems

Rook Quality Systems is a consulting firm dedicated to helping early-stage medical device companies develop and maintain effective and efficient quality systems. For over a decade, Rook has specialized in Quality and Regulatory strategies for emerging medical device clientele. 

At Rook, our mission is to enable clients to implement compliant Quality Management Systems (QMSs) so that they can efficiently produce effective and reliable medical devices. We build these QMSs so that our clients can get their devices to market faster than standard methods, and once on the market, manage these systems to continue producing quality devices. 

Rook provides clients with all of the right resources and necessary tools to comply with regulations in domestic and international markets. Rook's team provides expertise in FDA regulations, MDSAP audits, ISO 13485:2016 compliance, and MDR conformity. We work with a wide range of devices (including class I-III devices, SaMD, and IVDs). Visit their website to learn more.

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