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…

Safety Certification of Software Modules – What and Why is it?

Standards apply to products, services, and everything in between. Products, processes, services and even people can be certified. According to…

“Software of unknown provenance (SOUP) – The first course of action”

Today’s medical device manufacturers are faced with several challenges: developing innovative devices connected to in-home, hospital, and office networks and…

Security of Medical Devices – A Changing Regulatory Landscape

Over the past two decades, medical devices have been increasingly likely to be connected to the outside world using Wi-Fi,…

Missed the RISC-V Summit last week in San Francisco?

Missed the RISC-V Summit last week in San Francisco?

Don’t worry. We’ve got you covered. Before we dive deeper, here is a short video of Siemens Embedded, presenting a…