MKS is a global application lifecycle management (ALM) technology provider.
Varian Medical Systems, which is subject to US federal and international regulations, was searching for automated solutions to replace its manual processes and documents and increase management visibility.
Varian Medical Systems Imaging Products engineering manager Keith Gray said MKS Integrity allows them to trace the relationship between requirements and other development artifacts in real-time to impact analysis throughout the development cycle, helping to understand the progress made toward release readiness and compliance requirements.
"By managing engineering assets and documents with MKS Integrity, we have been able to generate reports and complete our regulatory submissions in a fraction of the time it took previously," Gray said.
MKS CTO Andrew Wertkin said their Integrity solution may help other medical device companies automate their own risk assessment procedures, enabling development teams to efficiently design potential risks out of the system – speeding development, driving down costs, and reducing risk- all with the goal of getting safe, cutting-edge medical devices out to the consumer sooner.
