More and more medical devices are taking advantage of the capabilities of Open Source Software like Linux, but using a non-certified operating system in a medical design introduces challenges when it comes time to achieve regulatory approval. In addition to utilizing an OS like Linux, more and more of these devices are connected to the outside world using the same internet that you use every day. While this connectivity of medical devices has had many benefits, when devices are connected to the internet, it is imperative that they are not only safe and effective, but they must also be secure. This webinar will discuss techniques expected by regulatory agencies that you should consider while designing, implementing, validating, and maintaining your Linux-based device, which will lead to a smoother path to approval.
Chief Safety Officer
Robert is responsible for safety, quality and security aspects of Siemens Embedded product portfolio targeting the Industrial, Medical, Automotive and Aerospace markets. In this role, Robert works closely with customers and certification agencies to facilitate the safety certification of devices to IEC 61508, ISO 26262, IEC 62304 and other safety certifications. Before moving to this position in 2014, Robert was a Software Development Director at Wind River, where he was responsible for commercial and safety certified operating system offerings, as well as both secure and commercial hypervisiors. Robert has 35 years of experience in the embedded software field, most of which has been spent developing Operating System and Middleware components to device makers across all markets and regions.