Co-Founder & CTO of BioT & AAMI contributing member
Chief Solutions Officer of Orthogonal & Co-Chair of AAMI’s Cloud Computing Working Group
Principal Solution Architect, Healthcare and Life Sciences, Compliance and Medical Devices, AWS & AAMI Contributing Member
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. Also, 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.
In this webinar you will learn:
- What challenges are TIR115 looking to solve and what does it mean to medical device companies and stakeholders?
- What are the implications for a medical device during design and initial commercialization phases?
- What are the implications once in the market as you operate and evolve a device and system?
- What best practices should be considered by Product/R&D , QA/RA, Enterprise Architecture, DevSecOps, Postmarket Surveillance and Support?