WATERLOO, ONTARIO, Oct. 2, 2009 (Marketwire) --
WATERLOO, ONTARIO -- (Marketwire) -- 10/02/09 -- 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® 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.
