Software in Medical Devices, by MD101 Consulting

We continue this series of articles on cybersecurity with a free and non-exhaustive review of UL 2900-1 standard.
What is UL 2900-1? This standard was published in 2017 by Underwriters Laboratory (UL). It contains technical requirements on cybersecurity for network connectable products. A collateral UL 2900-2-1 focuses on connectable healthcare and wellness systems. UL 2900-1 and UL 2900-2-1 are FDA recognized standards. Thus, applicable to medical devices.

Hi there! Long time no see once again. I dig up our series of posts on cybersecurity.
In this post I publish two new templates for cybersecurity risk management.

After a long pause, we continue this series about cybersecurity in medical devices with a discussion on AAMI TIR57:2016 Principles for medical device security — Risk management.

This article is a follow-up of the article on the Draft guidance on Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types.

We begin today a series of posts on cybersecurity in medical devices. Cybersecurity was not a subject before the advent of computerized medical devices. Now that every manufacturer wants its connected medical device, cybersecurity matters!
Let's start with the regulations.