Feature Article
Software Development for Medical Devices: Overcoming the Challenges of Compliance, Quality and Cost
Software is fast becoming the differentiator for manufacturers of medical devices. The rewards available from software innovation are balanced by the risks and challenges of FDA regulation, stringent quality requirements, market pressures, and significant complexity. Balancing these competing interests requires tailored application lifecycle management that addresses the unique needs of medical devices companies.
This paper reviews some of the key challenges facing the medical device industry, and examines the role that an application lifecycle management (ALM) platform can play in meeting these challenges. Primary challenges to be addressed include FDA compliance, device and software quality, and cycle time and cost.
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In The News
ALM boundaries are expanding in Application Development
By Colleen Frye, Feb. 10, 2010, SearchSoftwareQuality
While the pool of application lifecycle management (ALM) vendors tends to be dominated by four big swimmers -- IBM, HP, MKS and Microsoft -- it's a crowded space, with many players offering pieces of the solution. But the next wave is making the pool itself deeper, as the definition of "lifecycle" broadens, encompassing not only the development/test lifecycle, but requirements and architecture, portfolio management and operations.
To read more on this story, click here.
Unitron™ and MKS™ Named in Globe and Mail's Top 50 Best Small - Medium Employers in Canada
Article on Exchange Magazine, Posted February 8 , 2010
Waterloo Region - Two Waterloo companies, Unitron™ and MKS™ and respective employees are demonstrating high levels of loyalty and entrepreneurship resulting in consecutive growth year over year. Both companies will be named to the Top 50 Best Small and Medium Employers in Canada on February 10th. This annual survey by Queen's Centre for Business Venturing at the Queen's School of Business and Hewitt Associates, in partnership with The Globe and Mail, uses employee opinion to determine whether a company earns the status of being one of the best.
What makes them the best according to the people that work there? Employees at both companies believe their culture of innovation and the value placed on each individual's contributions are key factors to achieving the distinction. Unitron and MKS attract and retain exceptional employees who believe in the value of the companies' products. They also understand that their united efforts accomplish great things, which fuels a shared sense of purpose and drive. Both companies are showing consistent growth despite the recession. MKS is successfully competing against international giants like IBM, Hewlett-Packard and Microsoft, and Unitron with the likes of Siemens and William Demont.
To read more on this story, click here.
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Solving the Quality & Compliance Challenges for Embedded Software in Medical Devices
February 25: Embedded.com Webinar, Featuring CVRx
Developing software for medical devices means managing accelerating amounts of complex and interrelated software. CVRx makes the Rheos® System, an active implantable technology (Class-III, FDA-regulated) for the treatment of high blood pressure. Join John Stroebel from CVRx, when he will share his real-world insights and experiences in using ALM to address quality and compliance challenges, with full traceability and auditability across the lifecycle. Click here for registration details.
From Requirements to Finished App: Achieving Traceability for Change Across the Software Lifecycle
February 25 at 2:00 PM to 3:00 PM (EST)
Join us for a look at MKS Integrity and see how it delivers complete traceability between requirements, test cases, defects and related development activities. Learn how MKS Integrity can deliver traceability from a role perspective, enabling you to see the history of change from the view of a QA Manager, Business Analyst or any other stakeholder.
Click here to register.
Achieving Effective Compliance for Export Controlled Software in a Global Environment
March 24 at 3:00 PM GMT/11:00 AM EDT
Products today have high levels of software 'on board'. This Webinar explores the topic of Export Controlled software and how the introduction of supporting application lifecycle management technology can ease the burden of compliance and auditability, facilitate greater col-laboration and enhance performance and efficiency going forward. Register Now!
Systematic Testing - Standard Engineering Practices Applied to Software Testing
April 7 at 3:00 PM BST and 2:00 PM EDT
In recent years, software engineering practices have evolved, resulting in model driven development and a high degree of reuse and parameterization of software components. The aim of this Webinar is to highlight some standard engineering practices that can be applied to software testing, that allow testing teams to get greater reuse and value out of their test artifacts. This results in greater efficiency and productivity amongst the testing team and builds value in the organization.
Register here for 3:00 PM BST.
Register here for 2:00 PM EDT.
Making Agile Work in Highly Regulated Environments
April 14 at 3:00 PM BST and 2:00 PM EDT
Highly regulated industries-avionics suppliers, medical device companies, and pharmaceutical manufacturers for example must meet rigorous quality standards. In this Webinar, Customer Requirements Manager Colin Doyle will describe ways to leverage agile practices within regulatory constraints, offering specific examples from the commercial avionics standard DO-178B and FDA CDRH software validation guidelines.
Register here for 3:00 PM BST.
Register here for 2:00 PM EDT.
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February 26: Elektronikpraxis Webinar (in German) "Bessere Software mit Anforderungsbasiertem Teste"
March 19: Elektronikpraxis Webinar (in German) "Bessere Software mit Defect Management"
March 23 to 25: RPG & DB2 Spring Summit 2010 - IBM i Event Sheraton Fort Worth, Fort Worth, TX
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Tradeshows
March 2nd-4th: Embedded World - the world's biggest tradefair on Embedded Technologies taking place in Nuremberg, Germany. Register here.
March 16th-17th: Reconf - Requirements Management Conference taking place in Munich, Germany. Register here.
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Variability & Persistence - The Newest Additions to the QA Vocabulary
Testing is often one of the last activities in a development or engineering cycle purely due to the nature of evaluating constructed systems, and all too often an insufficient amount of time is set aside to adequately perform the desired level of testing. In order to rise to this challenge, testing teams must prioritize their work, evaluate risk and work with stakeholders to shift their software testing efforts to the most pressing areas.
This paper describes how the increasing complexity of software can derail the testing organization. It offers specific strategies that a QA team can use to overcome product or system complexity and provides details on how testing teams can build more reusable and persistent test assets to create more value in the testing lifecycle.
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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 www.mks.com or in Japanese www.mks-integrity.jp/.
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