Software in Medical Devices, by MD101 Consulting

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Tag - IEC 62366

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Friday, 6 July 2018

IEC 62366-1 and Usability engineering for software

Usability is a requirement, which has been present in regulations since a long time. It stems from the assessment of user error as a hazardous situation. It is supported by the publication AAMI HE75 standard, FDA guidances, and the publication of IEC 62366 in 2008 followed by IEC 62366-1:2015. Although usability engineering is a requirement for the design of medical devices, most of people designing software are not familiar with this process. This article is an application of the process described in IEC 62366-1 to software design.

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Friday, 11 March 2016

IEC 82304-1 - Overview of requirements

We had in a previous article an overview of IEC 82304-1 Health software -- Part 1: General requirements for product safety, its scope and its relationships with other standards like IEC 62304.
This article presents more in details (but not too much, we're not going to rephrase the standard) the requirements of IEC 82304-1.

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Wednesday, 23 September 2015

IEC 62366-1 becomes recognized by the FDA

Long time no see. For those of you guys who have been following this blog for a long time.
Today I have time to write a short article on the new version of IEC 62366 standard: IEC 62366-1:2105 Application of usability engineering to medical devices.

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Friday, 9 January 2015

IEC/FDIS 62366-1 released in November 2014

The FDIS (final draft version) of IEC 62366-1 was released in November 2014. This version, also known as IEC 62366 2nd edition, is on the right track to be officially released in Q1 2015. It will supersede the IEC 62366:2007 + Amendment 1:2014.

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Friday, 22 August 2014

When the next versions of IEC 62304 and IEC 62366 will be released?

Continuing with the schedule of the ISO TC 210 committee, let's see when the next versions of IEC 62304 and IEC 62366 will be released.

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Friday, 17 January 2014

How to develop a smartphone App to be FDA-cleared or CE Marked? - part 4 Usability

In the last article, we saw the concerns about the reliability of wireless connections and how to handle them.
Today, we are going to have a look at something quite important for mobile platforms: usability and humans factors engineering (HFE).

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Friday, 23 March 2012

Template: Usability Specification Document

After the Risk Managment Plan template, here is the Usability Specification Document.

The Usability Specification Document is your companion during the phases where you define the graphical user interface and ergonomics of your software.

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Friday, 9 March 2012

Inflation of software medical devices - part 1

Don't worry, I'm not going to talk about money and quantitative easing! I let people with better knowledge in economics (that makes a lot of people!) do that.
When I talk about inflation, I mean the inflation of software medical devices in their number and variety, which creates a collateral inflation in the number of regulations, guidances, standards, and the like.
This post is the first of a series of three. In this first post, I focus on the inflation of standards. The next one will be on the inflation of regulations and the last one on the inflation of medical devices.

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Friday, 18 November 2011

Software Medical Devices. How to obtain market homologation?

The homologation of a medical device is a complex task and can become a nightmare with devices with a high level of risk. It involves many standards and regulations, different from one country to another: FDA in the USA, CE Mark in Europe, CMDCAS in Canada, KFDA in South Korea, and so on …

Fortunately, most of these regulations have common requirements and rely on ISO standards, the most important standards being ISO 13485 and ISO 14971. If you meet the requirements of these standards, you increase your chances of passing the homologations for the devices with low risk. For devices with high risk, these standards are (almost) mandatory.

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Tuesday, 1 November 2011

ISO and IEC standards for software in medical devices in a nutshell

Here is a short description of ISO and IEC standards related to software and medical devices.

The starting point is legal. Government agencies give the authorizations to manufacturers to sell their devices. These agencies rely on standards to ensure that the device was designed and manufactured in a good and safe way. Given these regulations, medical device manufacturers have to adhere to these standards. Full stop.

Let's see what these standards are.

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