Webinar | Cloud Change Control Guidance for Medical Devices: Introductions and Insights | Orthogonal

This video is a recording of a live webinar organized by BioT Medical that took place on November 9th, 2023. The event featured an introduction to emerging guidance for medical devices that use the cloud.
***
AAMI, an ANSI-accredited standards organization focused on the medical device industry, has guidance under development (TIR115) to extend current guidance for building safe and effective medical devices when device functions now operate on public clouds.
There are certainly benefits for medical devices and public cloud services. However, new risks can be introduced when responsibility and lack of direct control for computing infrastructure shifts from the device manufacturer to a cloud services provider.
This introduces the need for new and modified approaches to change control for cloud-powered medical devices. These approaches must address the ongoing needs of the many stakeholders associated with a medical device: Product/R&D, QA/RA, Enterprise Architecture, DevSecOps, Postmarket Surveillance & Support, etc.
This one-hour webinar serves as an introduction to the in-development AAMI guidance (TIR115) and shares emerging best practice insights for stakeholder groups.
***
Expert speakers on this webinar:
*Ian Sutcliffe, Principal Technology Strategist, Amazon Web Services
*Randy Horton, Chief Solutions Officer, Orthogonal
*Guy Vinograd, Co-Founder & CTO of BioT Medical
*John Miller, Vice President, Americas, BioT Medical