About this Event
How Software Engineers and Compliance Professionals Can Become Best Friends: The Automation of QA/RA
In MedTech R&D organizations, software engineers frequently seem at odds with their quality and regulatory (Q&R) peers, bringing very different perspectives on the best way to prove that the software in a medical device is safe and effective.
The truth is that this gap is an issue of communication, and not an issue of having fundamentally different perspectives about quality. The tools and techniques of modern software engineering can be quite compatible with the documentation needs of Q&R. By leveraging the value of automation in software product engineering, rather than clashing, software engineers and quality and regulatory professionals have the potential to evolve into “best friends.”
Join BioT, AWS, and Orthogonal for an Internet of Medical Things (IoMT) MeetUp in Tel Aviv, where a panel of modern MedTech software pioneers will discuss best practices and case studies from organizations that have applied software automation to improve their Q&R game.
The meetup is intended for product, engineers, architecture, and regulation role owners in medical device companies.
Speakers and panelists include:
- Randy Horton, Chief Solutions Officer, Orthogonal
- Itai Weissman, VP of Product, Bio-T Medical
- Ian Sutcliffe, Principal Software Architect, Healthcare and Life Sciences Compliance and Medical Devices, Amazon Web Services (AWS)
Date: July 21, 2024. 18:00-20:00 (ISR Time)
Location: Azrieli Sarona Tower
Biographies of the speakers and panelists:
Randy Horton is Chief Solutions Officer at Orthogonal, serves as Co-Chair for AAMI’s Cloud Computing Working Group, as well as AAMI CR:510(2021) and the in-process Technical Information Report #115, all of which address how to safely move medical device computing functions into the cloud. He is a frequent speaker at conferences and webinars, including events hosted by AdvaMed, AAMI, HLTH/VIVE, RAPS and the Human Factors and Ergonomics Society (HFES).
Itai Weissman is VP Product at BioT, previously VP Product at an Israeli Nasdaq-traded company specializing in SaaS solutions for Cyber analytics and communications. BioT specializes in providing a no-code medical grade and fully secured cloud-based platform for building distributed medical devices in record time - instead of years, in just one day.
Ian Sutcliffe, Principal Software Architect, Healthcare and Life Sciences Compliance and Medical Devices, Amazon Web Services (AWS), with nearly 30 years of experience in IT, primarily in the Life Sciences industry. A thought leader in the area of regulated cloud computing, and intent on helping customers become Regulated Cloud Natives.
Bring your ID or driving license with you, in order to enter the AWS building.
Event Venue & Nearby Stays
Derech Menachem Begin 121, 121 Derech Menachem Begin, Tel Aviv-Jaffa, Israel
USD 0.00