Plano, Texas, 08 May 2018

Siemens’ new Digital Enterprise Industry Solution for Medical Devices provides integrated traceability for design processes

  • Manufacturers can achieve significantly improved quality and regulatory compliance through end-to-end traceability and automated audit trails
  • Provides a flexible, browser-based, integrated system with a single source of information to help increase collaboration and reduce errors

Siemens announces a new Digital Enterprise Industry Solution for the medical device industry, Intelligent Design Control. The solution addresses the challenges medical device manufacturers are currently facing due to intensified regulatory requirements as a result of increasingly complex devices and design processes. By managing an integrated design process in the context of risk management, the Intelligent Design Control solution helps provide enhanced visibility into design processes with the ability to make real-time design and development modifications to help meet validation and verification requirements. This solution focuses on the elements of device design rather than the device documents. By reorganizing each into smart, searchable data models specific to the relevant stakeholders, companies can avoid copy errors, ensure data integrity, create trace reports, and enable extensive search, reuse, and analysis of design information. The ability to analyze and mitigate risk within the design environment lends to increased innovation with a reduction in time to market.

“Medical device companies are starting to recognize the need for digital, data-driven processes as devices and designs are becoming increasingly complex,” said Jim Brown, president of independent research firm Tech-Clarity. “A digital approach provides cohesive, connected processes with the ability to reuse designs and simulate product performance. The result is faster time to market, balanced risk, higher quality, lower costs, and continuous innovation.”

Intelligent Design Control not only links design elements by connecting potentially hazardous situations to requirements to test cases, but goes even further by providing traceability across the entire product engineering domain. This solution, unique in the marketplace, offers an open platform combining end-to-end automation, from design to part construction and into manufacturing execution. This allows for validation and verification of all inputs and outputs, with the ability to make on-the-spot modifications as needed for regulatory and risk management requirements. As medical device design involves both high risk and highly complex devices and processes, automating the entire design process is a crucial next step to eliminating errors and meeting regulatory demands. 

Additionally, by providing comprehensive visibility into design requirements which may need updating and the ability to make real-time adjustments to help avoid costly errors Intelligent Design Control represents simple yet accurate device design technology. With easy-to-use and easy-to-adjust project templates, medical device manufacturers can also avoid problematic gaps which can occur when working across separate systems and geographic locales, as this flexible model can turn the existing design landscape into a connected digital enterprise. This extends the unique ability to effectively manage risk in a cohesive way, which can result in faster and higher quality designs and the development of medical devices with advanced features and capabilities. 

“Device design is becoming an increasingly common cause for product recalls within the medical device industry, which only re-emphasizes the need for an integrated risk management strategy,” said Laurence Sampson, senior director of Medical Industry Strategy, Siemens PLM Software. “The Intelligent Design Control solution gives medical device manufacturers critical visibility into each step of the process, allowing for risks to be mitigated more quickly and more easily. Avoiding quality issues earlier in the product lifecycle can help avoid recalls or other adverse events, all while helping create innovative solutions for those in need of these potentially life-saving devices.” 

To learn more about Siemens’ solutions for the medical device industry, please see: 

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Siemens PLM Software, a business unit of the Siemens Digital Factory Division, is a leading global provider of software solutions to drive the digital transformation of industry, creating new opportunities for manufacturers to realize innovation. With headquarters in Plano, Texas, and over 140,000 customers worldwide, Siemens PLM Software works with companies of all sizes to transform the way ideas come to life, the way products are realized, and the way products and assets in operation are used and understood. For more information on Siemens PLM Software products and services, visit

Siemens AG (Berlin and Munich)is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for 170 years. The company is active around the globe, focusing on the areas of electrification, automation and digitalization. One of the world's largest producers of energy-efficient, resource-saving technologies, Siemens is a leading supplier of efficient power generation and power transmission solutions and a pioneer in infrastructure solutions as well as automation, drive and software solutions for industry. The company is also a leading provider of medical imaging equipment – such as computed tomography and magnetic resonance imaging systems – and a leader in laboratory diagnostics as well as clinical IT. In fiscal 2017, which ended on September 30, 2017, Siemens generated revenue of €83.0 billion and net income of €6.2 billion. At the end of September 2017, the company had around 372,000 employees worldwide. Further information is available on the Internet at

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