Every year, the Association for the Advancement of Medical Instrumentation (AAMI) awards a prize to the best article contributed to an AAMI publication. Among the several dozens of articles that were published in AAMI’s journal BI&T, the organization chose “Hey You, Get On the Cloud: Safe and Compliant Use of Cloud Computing with Medical Devices’‘ as the best article of 2021.
Orthogonal’s Randy Horton and Bernhard Kappe were excited to receive this award, alongside co-writers Clay Anselmo, principal quality and regulatory consultant at Shriner & Associates, Mike Attili, president of Amaxo Inc, Josh Schulman, chief scientific officer at Joy Ventures and Pat Baird, regulatory head of global software standards at Philips. They also want to thank the staff at AAMI for their great ongoing work.
AAMI partners with experts to create standards that shape our industry. After publishing “Hey You, Get On the Cloud”, AAMI saw the value of creating a Consensus Report on the subject of medical devices and cloud computing. The co-writers of the article and other experienced figures in our industry convened under AAMI’s authority to create AAMI CR510:2021, Appropriate use of public cloud computing for quality systems and medical devices. Currently, AAMI Technical Information Report (TIR) #115, which builds on the work of the Consensus Report, is underway, with many of the article and CR contributors reprising their roles alongside new contributors. This TIR will set the most definitive (and currently only) guidance of how the MedTech industry thoughtfully and responsibly approaches the use of the cloud in the operation of medical devices. Orthogonal is thrilled to have partnered with our other industry colleagues in the CR Working Group, and to have been able to do this with AAMI’s formal support and sponsorship.
Learn more about Orthogonal and other industry experts’ partnership with AAMI in defining guidance around using cloud computing in the operation of medical devices: