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…

Siemens Embedded free open-source toolchain enables the power and performance of AMD devices

With today’s growing demand for applications that require high-performance computing (HPC) and artificial intelligence (AI), Siemens Embedded Software and Advanced…

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,…

Quality Considerations of Open-Source Software for Medical Devices

Traditionally, software intended to run on a medical device was expected to be written by companies well versed in writing…

Nucleus:13 is Proof the System Works

Nucleus:13 is Proof the System Works

On November 9, 2021, Forescout announced the discovery of several new security flaws in the Nucleus Networking stack, which they…

Medical Devices MUST Be Secure

 I recently had the opportunity to present in a Webinar focusing on security needs of medical devices along with Patrick…