Embedded Systems Design Europe - May 2008 - (Page 26) medical static analysis BY RAOUL JETLEY AND PAUL ANDERSON Using Researchers at the FDA’s Office of Science and Engineering Laboratories investigating new techniques for analyzing software in medical devices are using static analysis tools to uncover potential flaws in a device under review. to evaluate software in medical devices T 26 he Center for Devices and Radiological Health (CDRH) at the FDA is responsible for post-market surveillance of medical devices. If a device failure resulting in actual or potential serious injury or death is reported, the manufacturer of the medical device is required to investigate, determine the root cause and contributory factors, develop appropriate corrective actions, and report their findings to CDRH. In cases where the adequacy of the manufacturer’s investigation or corrective action is in question, CDRH may conduct an independent investigation. Commensurate with the threat to public health, CDRH can unilaterally take a range of actions, including issuing public health notifications or mandating a product recall. Performing a post-market investigation, however, is not an easy task. This is particularly true in the case of software, where the execution is often user-driven and system-specific. To further complicate matters, device software is usually event-driven, resulting in failures that are often unpredictable and may not be easily reproducible. In such cases, the only way to trace the software flaws has historically been to manually review the source code itself. Given the complexity of modern medical-device software, this is a very difficult and time-consuming task for a third-party investigator with MAY 2008 | embedded systems design europe | www.embedded.com/europe http://www.embedded.com/europe
Table of Contents Feed for the Digital Edition of Embedded Systems Design Europe - May 2008 Embedded Systems Design Europe - May 2008 Contents Microsoft Provides Embedded Roadmap Enea Buys Developers Irish Start-Up Raises Funds for Telecom FPGAs Kontron Promotes COM Express Nano Mentor Nucleus Platform Provides UI for Atmel Small Form Factor Boards Head for the SUMIT Proffibus Advances IO-Link Integration Embedded Developers Cautious on Multicore Auto Cooperation Improves Test Altera Launches DO-254 Partner Network Building an ‘Instant-Up’ Real-Time Operating Systems An Architecture for Reusable Embedded Systems Software Free up Bandwidth in PCI Express Evaluating Software in Medical Devices Circuit Sensitivity in Analog Circuits Choosing Flash Memory New Products Advertising Contacts Embedded Systems Design Europe - May 2008 Embedded Systems Design Europe - May 2008 - Embedded Systems Design Europe - May 2008 (Page 1) Embedded Systems Design Europe - May 2008 - Embedded Systems Design Europe - May 2008 (Page 2) Embedded Systems Design Europe - May 2008 - Contents (Page 3) Embedded Systems Design Europe - May 2008 - Contents (Page 4) Embedded Systems Design Europe - May 2008 - Contents (Page 5) Embedded Systems Design Europe - May 2008 - Microsoft Provides Embedded Roadmap (Page 6) Embedded Systems Design Europe - May 2008 - Microsoft Provides Embedded Roadmap (Page 7) Embedded Systems Design Europe - May 2008 - Irish Start-Up Raises Funds for Telecom FPGAs (Page 8) Embedded Systems Design Europe - May 2008 - Irish Start-Up Raises Funds for Telecom FPGAs (Page 9) Embedded Systems Design Europe - May 2008 - Mentor Nucleus Platform Provides UI for Atmel (Page 10) Embedded Systems Design Europe - May 2008 - Mentor Nucleus Platform Provides UI for Atmel (Page 11) Embedded Systems Design Europe - May 2008 - Proffibus Advances IO-Link Integration (Page 12) Embedded Systems Design Europe - May 2008 - Altera Launches DO-254 Partner Network (Page 13) Embedded Systems Design Europe - May 2008 - Building an ‘Instant-Up’ Real-Time Operating Systems (Page 14) Embedded Systems Design Europe - May 2008 - Building an ‘Instant-Up’ Real-Time Operating Systems (Page 15) Embedded Systems Design Europe - May 2008 - Building an ‘Instant-Up’ Real-Time Operating Systems (Page 16) Embedded Systems Design Europe - May 2008 - Building an ‘Instant-Up’ Real-Time Operating Systems (Page 17) Embedded Systems Design Europe - May 2008 - An Architecture for Reusable Embedded Systems Software (Page 18) Embedded Systems Design Europe - May 2008 - An Architecture for Reusable Embedded Systems Software (Page 19) Embedded Systems Design Europe - May 2008 - An Architecture for Reusable Embedded Systems Software (Page 20) Embedded Systems Design Europe - May 2008 - An Architecture for Reusable Embedded Systems Software (Page 21) Embedded Systems Design Europe - May 2008 - Free up Bandwidth in PCI Express (Page 22) Embedded Systems Design Europe - May 2008 - Free up Bandwidth in PCI Express (Page 23) Embedded Systems Design Europe - May 2008 - Free up Bandwidth in PCI Express (Page 24) Embedded Systems Design Europe - May 2008 - Free up Bandwidth in PCI Express (Page 25) Embedded Systems Design Europe - May 2008 - Evaluating Software in Medical Devices (Page 26) Embedded Systems Design Europe - May 2008 - Evaluating Software in Medical Devices (Page 27) Embedded Systems Design Europe - May 2008 - Evaluating Software in Medical Devices (Page 28) Embedded Systems Design Europe - May 2008 - Evaluating Software in Medical Devices (Page 29) Embedded Systems Design Europe - May 2008 - Circuit Sensitivity in Analog Circuits (Page 30) Embedded Systems Design Europe - May 2008 - Circuit Sensitivity in Analog Circuits (Page 31) Embedded Systems Design Europe - May 2008 - Circuit Sensitivity in Analog Circuits (Page 32) Embedded Systems Design Europe - May 2008 - Circuit Sensitivity in Analog Circuits (Page 33) Embedded Systems Design Europe - May 2008 - Circuit Sensitivity in Analog Circuits (Page 34) Embedded Systems Design Europe - May 2008 - Circuit Sensitivity in Analog Circuits (Page 35) Embedded Systems Design Europe - May 2008 - Choosing Flash Memory (Page 36) Embedded Systems Design Europe - May 2008 - Choosing Flash Memory (Page 37) Embedded Systems Design Europe - May 2008 - Choosing Flash Memory (Page 38) Embedded Systems Design Europe - May 2008 - Choosing Flash Memory (Page 39) Embedded Systems Design Europe - May 2008 - New Products (Page 40) Embedded Systems Design Europe - May 2008 - New Products (Page 41) Embedded Systems Design Europe - May 2008 - New Products (Page 42) Embedded Systems Design Europe - May 2008 - Advertising Contacts (Page 43) Embedded Systems Design Europe - May 2008 - Advertising Contacts (Page 44)
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