Three pillars of medical device safety development

Establishing the safety and security of medical device software is critical to protect patients. The IEC 62304 standard provides a…

Device Security: You vs. Future Security Vulnerabilities

If testing and protecting your device from known issues, is equivalent to closing a treasure vault’s door, by that analogy,…

Reducing the Risk of Using Linux® with PolarFire® SoC FPGAs

More than ever, embedded devices of today are leaning on open source solutions like Linux. The ease, versatility, and flexibility…

Safety Software Development Process and IEC 62304 Compliance

While the need, use, or device may be disparate, safety software development has common themes across industries. IEC 62304 does…

Safety, Security and IEC 62304 Compliance

Before we begin, let’s define and disambiguate safety and security. Safety is about protecting people and equipment when a device…

Siemens among industry leaders in commercial grade Linux support for RISC-V 

Siemens’ Linux-based SokolTMFlex OS software now supports RISC-V embedded development. Based on the popular, open-source Yocto Project industry standard, SokolTMFlex…

Quality and Open-Source Software in Medical Devices

Many companies are using Open-Source Software (OSS) such as Linux in devices across every imaginable industry. Linux (and packages that…

Using open source vs. commercial Linux

Using Linux in your medical device has plenty of advantages. A successful migration to embedded Linux can bring numerous advantages…

Medical Devices and the FDA, a History of Change

As you probably know, devices of all types continue to get more complex, more interconnected, and in the world of…