Kardium Selects MKS Integrity

Using MKS Integrity as the Application Lifecycle Management Product for Development of Breakthrough Solutions

MKS Inc. the global application lifecycle management (ALM) technology leader, today announced that Kardium, a pioneer in the development of medical devices for cardiovascular patients, has selected MKS Integrity™ as the application lifecycle management product of choice for the development of breakthrough solutions for cardiovascular diseases. MKS Integrity will be used in Kardium’s research and development facility, created to commercialize several patent pending concepts.

The founders of Kardium recognized that developing sophisticated medical devices for this highly competitive market required a product to orchestrate the management of all engineering artifacts including requirements, specifications, and test. In order to meet both safety and time-to-market goals, the solution needed to automate global regulatory reporting and scale easily, as well as enable trace management and accommodate Kardium product development processes.

“Kardium's goal is to grow the company quickly with a strong set of unique, compelling products to improve the health and extend the lifespan of cardiac patients worldwide. To meet our aggressive schedules, we needed an integrated, out-of-the box solution with quick time-to-value. Based on a very thorough evaluation, we selected MKS Integrity over a home-grown solution and other packaged products due to its completeness and configurability – features which will help us reduce development cycle time and improve product quality,” said Doug Goertzen, CEO at Kardium. “Developing our own custom solution did not make economic sense for us, and other products we looked at required more integration or had less functionality. Our business depends on getting quality products to market before our competitors.”

“For all medical devices, including those categorized by the FDA as Class 3, which present the highest risk but also the greatest potential value to patients, MKS Integrity provides a comprehensive product that streamlines compliance, minimizes risk, and improves the safety and quality of products. We are excited that Kardium is leveraging the power of MKS Integrity to speed the development and introduction of innovative medical devices that will improve cardiac health and we look forward to a long partnership,” said Michael W. Harris, President and CEO at MKS.

About MKS
MKS Inc., the global application lifecycle management (ALM) technology leader, enables software engineering and IT organizations to seamlessly manage their worldwide software development activities. With its flagship product, MKS Integrity, MKS offers support for all software development activities through a single enterprise application, resulting in better global collaboration and higher productivity. MKS supports customers worldwide with offices across North America, Europe and Asia. For more information about MKS, visit our web site at http://www.mks.com.

About MKS Integrity
MKS Integrity unites the stakeholders of software development through a single source of truth for all processes, activities and assets, to manage complexity and solve the most challenging business problems. MKS Integrity provides a complete range of software product development competence, delivered in a platform that offers coherence across the application lifecycle while rapidly adapting to meet unique enterprise needs. More information about MKS Integrity in the medical devices industry is available at http://www.mks.com/solutions/by-industry/medical-devices