Key Considerations for SaMD Companies Developing and Commercializing Software as Medical Devices

In recent years, FDA released several guidance documents and launched initiatives to better advance the development of digital health tools with the goal to allow all Americans to have timely access to high quality, safe, and effective digital health products.

Software as Medical Device (SaMD) is one specific type of software related to medical device that is getting increased attention from all stakeholders because of its unique trait to be used across a broad range of technologies (e.g. medical device platforms, commercial “off-the-shelf” platforms, and virtual networks...etc).

From the manufacturers’ perspective, the top priority is to understand and interpret the regulatory implications from the guidances, harmonized standards, white papers, initiatives in order to translate that to actual development, production, and quality assurance practices in a time-efficient and cost-effective manner.

We've teamed up with Rook Quality Systems to share their expertise on the topic and to provide their insights from working with clients with SaMD products throughout the software development lifecycle all the way to regulatory approval.

This in-depth webinar will cover the most important items that companies must understand and put into practice when developing and commercializing SaMDs.

Watch the webinar

SaMD webinar_andrew-wu-rook-qs
Specifically, this webinar will cover:
  • Recent FDA cleared SaMDs overview
  • Why FDA is placing such emphasis on regulating software
  • Why the IMDRF Framework and GMLP (Good Machine Learning Practice) can be critical throughout the software development lifecycle
  • How a regulatory strategy can impact software development greatly
  • What FDA is looking for from SaMD manufacturers in premarket submission
  • Upcoming FDA workshop – Evolving Role of Artificial Intelligence in Radiological Imaging
  • Q&A Session
Who Should Attend?
  • Medical Device Executives
  • Regulatory Affairs Professionals and Management
  • Quality Professionals and Management
  • R&D Engineers and Management
Register Now  

Hosted by

Presenter: Andrew Wu

Branch Manager & Software Consultant, Rook Quality Systems

Moderator: Mike Gadus

Director of Product Marketing, Greenlight Guru


About Rook Quality Systems

Rook Quality Systems provides specialized and custom consulting services for all classes of medical devices. We work with you to outline your quality and business goals to develop innovative and efficient practices that improve compliance and profit. You can see a full list of the service offerings from Rook Quality Systems by visiting their website to learn more.


About Greenlight Guru

Greenlight Guru is the only Medical Device Success Platform (MDSP) for companies to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based software, Greenlight Guru is easier to implement, easier to use and designed to fit all medical device needs to enable innovative, safe and effective, True Quality medical devices. Visit our homepage to learn more.

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