Tag - Cybersecurity - Software in Medical Devices, by MD101 Consulting

Friday 16 August 2019

Cybersecurity in medical devices: a short review of UL 2900-1

By Mitch on Friday 16 August 2019, 13:44 - Standards

Cybersecurity

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.

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Thursday 24 January 2019

Cybersecurity - Draft guidances from FDA and Health Canada

By Mitch on Thursday 24 January 2019, 12:50 - Regulations

The US FDA published in October 2018 a new draft version of its guidance on the content of premarket submissions for management of cybersecurity in medical devices. Two months later, Health Canada published in December 2018 a draft guidance document on pre-market requirements for medical device cybersecurity.

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Monday 15 October 2018

Cybersecurity - Part 5 Templates

By Mitch on Monday 15 October 2018, 14:58 - Templates

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.

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Monday 3 July 2017

Cybersecurity in medical devices - Part 4 Impact on Software Development Process

By Mitch on Monday 3 July 2017, 14:06 - Regulations

We continue this series of posts on cybersecurity with some comments on impacts of cybersecurity on the software development documentation.

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Tuesday 16 May 2017

Cybersecurity in medical devices - Part 3 AAMI TIR57:2016

By Mitch on Tuesday 16 May 2017, 21:53 - Standards

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.

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Friday 10 February 2017

Final FDA Guidance on Postmarket Management of Cybersecurity in Medical Devices - Final version released

By Mitch on Friday 10 February 2017, 14:20 - Regulations

This article is a follow-up of the previous article on the Draft guidance on Postmarket Management of Cybersecurity in Medical Devices.

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Final FDA Guidance on Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types

By Mitch on Friday 10 February 2017, 14:19 - Regulations

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.

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Tuesday 20 December 2016

Cybersecurity in medical devices - Part 2 Stakeholders

By Mitch on Tuesday 20 December 2016, 12:51 - Misc

Cybersecurity

After a long interruption, we continue this series on cybersecurity in medical devices with a review of stakeholders involved or concerned by cybersecurity requirements, and the consequences on architectural choices.

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Monday 24 October 2016

Cybersecurity in medical devices - Part 1 Regulations

By Mitch on Monday 24 October 2016, 16:50 - Regulations

Cybersecurity

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.

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Software in Medical Devices, by MD101 Consulting