MKS Inc.

MKS Inc.

October 02, 2009 14:01 ET

FDA Compliance for Medical Devices: Mouse-Clicks Instead of Person-Weeks

Intuitive Surgical Inc. Selects MKS Integrity Solution for Requirements Management Across Hardware and Software Components

WATERLOO, ONTARIO--(Marketwire - Oct. 2, 2009) - MKS Inc. (TSX:MKX) today announced that Intuitive Surgical Inc., has selected MKS Integrity(TM) for its requirements management needs. The initial implementation will capture system-level requirements, specifications, risks, verifications and validations in a single coherent platform. The solution will provide complete versioning and approval control over all artifacts while automatically establishing trace relationships between and among all of the artifacts. Immediate benefits to Intuitive Surgical will include improved efficiency and capacity for traceability demands associated with managing the parallel delivery cycles of a complex medical product.

Intuitive Surgical, Inc. (NASDAQ:ISRG) is the global technology leader in robotic-assisted minimally invasive surgery (MIS). The Company's da Vinci(R) Surgical System offers surgeons superior visualization, enhanced dexterity, greater precision and ergonomic comfort for the optimal performance of MIS. The da Vinci System enables surgeons to perform even complex procedures such as open-heart surgery through 1-2 cm incisions.

"As a Class II medical device, our da Vinci Surgical System is subject to regulation by the FDA under the Code of Federal Regulations Title 21," said Sal Brogna, VP Engineering of Intuitive Surgical, Inc. "The hardware, mechanical and optical components as well as the embedded software in the system are all impacted by this governance requirement. A key part of complying with this regulation is our ability to generate a traceability matrix as part of an FDA submission. The matrix for a sophisticated device such as ours might include up to eight or nine hundred interrelated documents. The generation and validation of this traceability matrix, while critically important, requires a significant human resource investment when done manually. With MKS Integrity we are able to generate these matrices in minutes with a few mouse clicks. We anticipate many benefits from using MKS Integrity but this capability alone will further enhance our ability to bring our products to market rapidly while mitigating the risk of compliance issues and reducing the cost of compliance."

MKS Integrity allows medical device companies to easily capture and version Requirements, Specifications, Risks, Mitigations, Test Cases, Change Requests, Defects and other artifacts. These artifacts are interrelated with defined named relationships to produce hierarchies and trace relationships that exactly match the processes and needs of medical device organizations. A Requirement may have multiple related risks and each risk may have multiple mitigations. With support for both "top-down" and "bottom-up" analysis on the same platform, full traceability is ensured. MKS Integrity enables organizations to more efficiently meet the requirements of the FDA Design Control process, rapidly providing needed reports and documentation like a Device Master Record (DMR) or Device History File (DHF).

Mr. Brogna continued, "Beyond the ability of MKS Integrity to meet our immediate needs and radically reduce the effort to report as needed to the FDA, we were impressed with the innate adaptability of the platform. As our needs and the regulations that affect us continue to evolve, the ability to rapidly adapt the solution to meet those needs will provide significant ongoing value to Intuitive Surgical."

"We have a successful track record with demanding customers facing similar engineering and governance challenges, and we were a great fit for Intuitive Surgical's ALM needs," said Chris Murray, Sales Director (Western Region) of MKS. "Our domain expertise and industry solutions for medical devices organizations will enable Intuitive Surgical to achieve immediate benefits in terms of automating time-intensive manual processes for compliance and reporting. We can provide dramatic benefits by aggregating and controlling the interrelated information assets for hardware, software, mechanical and optical components into a single coherent solution, but this is just scratching the surface of what can be achieved. The innate agility of the MKS Integrity solution will be the greatest driver of value for Intuitive Surgical as time goes on, enabling them to reconfigure their ALM processes and assets to address new needs and emerging best practices."

About MKS

MKS Inc., the global application lifecycle management (ALM) technology leader, enables organizations to seamlessly manage their worldwide software planning, development and maintenance activities. With its flagship product, MKS Integrity, MKS offers support for all software-related activities and assets through a single enterprise application, resulting in improved global collaboration and greater productivity. MKS has become an essential partner in addressing the challenges of software complexity faced by leading enterprises in various geographies and industries. Our wide array of industry and ALM experience allows our professional services teams to deliver superior solution value to our customers, from offices across North America, Europe and Asia. For more information about MKS, visit our Web site at

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.

Copyright (C) 2009 MKS Inc. MKS, MKS Integrity, Intelligent ALM and all other MKS brand and product names are trademarks of MKS Inc. All other marks mentioned are the property of their respective owners.

This news release contains forward-looking statements that involve risks and uncertainties, which may cause actual results to differ materially from the statements made. When used in this document, the words "may", "would", "could", "will", "intend", "plan", "anticipate", "believe", "estimate", "expect" and similar expressions are intended to identify forward-looking statements. Such statements reflect MKS's current views with respect to future events and are subject to such risks and uncertainties. Many factors could cause our actual results to differ materially from the statements made including those factors detailed from time to time in filings made by MKS with Canadian securities regulatory authorities. Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward looking statements prove incorrect, actual results may vary materially from those described herein as intended, planned, anticipated or expected. Although MKS believes the expectations represented by such forward looking statements are reasonable, there can be no assurance that those expectations will prove to be correct. MKS does not intend and does not assume any obligation to update these forward-looking statements.

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