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FREE On-demand webinar

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

 

Watch the free webinar


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.

 

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

 

Presenter

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Andrew Wu
Branch Manager & Software Consultant
Rook Quality Systems

Moderator

 Mike-Gadus-(LinkedIn)DHS_1829

Mike Gadus
Director of Product Marketing
Greenlight Guru

 

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About greenlight guru

Greenlight Guru is a modern quality management software platform used by medical device companies in over 25 countries to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based eQMS, Greenlight Guru is easier to implement, easier to use and simply fits medical device processes out-of-the-box allowing companies to innovate faster and be more efficient. Visit our homepage to learn more.

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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. To see a full list of the services Rook offers you can go here.

 

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