FREE ON-DEMAND WEBINAR
Top Things You Should Know When Developing Software As A Medical Device (SaMD)
With the rapid innovation in digital health such as Artificial Intelligence, wearable devices, web applications, and more comes and necessitates an evolving regulatory landscape.
The Software as a Medical Device guidance (SaMD) was adopted by the FDA along with global regulatory leaders to ensure such software products adopt the same general medical device principles to demonstrate safety, effectivity and performance.
This growing subset in the medical device industry introduces many software development companies to the medical device field. However, any company that manufactures SaMD faces rigorous regulatory requirements especially as it relates to their quality management system.
This free, in-depth webinar will be presented by Shawnnah Monterrey of Beanstock Ventures who will provide a detailed overview of SaMD, the latest updates to the regulations, and how to effectively implement and adapt a QMS for SaMD.
Watch the webinar
Specifically, this webinar will cover:
- Determining if your device and/or software is SaMD
- Understanding aspects influencing safety, effectivity, and performance
- Classifying your SaMD amidst the changing regulations
- Adopting (or adapting) your QMS for SaMD
- Taking the practical next steps to market
- Q&A Session
Who Should Attend?
- Quality Professionals and Management
- Regulatory Affairs Professionals and Management
- Software Development Engineers and Management
- Medical Device Executives
