Software in Medical Devices, a blog by MD101 Consulting

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Tag - ISO 14971

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Friday 22 July 2016

Is my software in class I, IIa, IIb or III - 2016 Revolution

The final version of the negotiated text of the new Medical Device Regulation (MDR) was published by the European Commission in June 2016. It is a big upheaval for all medical device manufacturers. Contrary to what the draft version of September 2015 contained, software is invited to the party.

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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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Friday 15 January 2016

IEC 82304-1 - latest news about the standard on Health Software

IEC 82304-1 Health software -- Part 1: General requirements for product safety standard is still under development. Its status is visible on the page of ISO website, dedicated to IEC 82304-1. There is even a preview of the first three pages of this draft standard.

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Friday 24 July 2015

Validation of software used in production and QMS - Part 2 Validation Master Plan

We continue this series on validation of software used in production and QMS with the Validation Master Plan (VMP).
Better than endless explanations, I added a Validation Master Plan template to my templates repository page.

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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 27 June 2014

ISO/DIS 13485:2014 strengthens requirements about software - Part 2

Continuing with ISO/DIS 13485:2014, after having made an overview of software-related changes in the last article, let's focus on the new clause #4.1.6.

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Friday 13 June 2014

ISO/DIS 13485:2014 strengthens requirements about software - Part 1

ISO/DIS 13485:2014 is the draft of the next version of ISO 13485. The final version should be published in 2015.
This new version brings a lot of new requirements for management of software related to medical devices. Let's see what's inside this draft!

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Friday 3 January 2014

How to develop a smartphone App to be FDA-cleared or CE Marked? - part 3 Wireless

In the last article, we explained why agile methods are so popular for mobile app software development. Today, we are going to review a major characteristic of mobile platforms: wireless connection.

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Friday 4 October 2013

Template: Risk Matrix Calculator

Risk matrixes are a useful way to show graphically the ranges in which risks are acceptable, tolerable and unacceptable. Here is an excel sheet that automates the computation of ranges.

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Friday 6 July 2012

Class C software and agile methods

Are agile methods compatible with the constraints of development set by IEC 62304 standard of class C software?
After a series of three posts about agile methods and risks analysis. I focus in this post on IEC 62304 class C critical software.

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Saturday 23 June 2012

How to combine risk management process with agile software development? - Part 3

We've seen in my last post that it's possible to have agile development methods combined with a risk management process. To be compliant with ISO 14971 standard, a risk management plan that describes this process along iterations, has to be written. And a risk assessment report has to be created in iteration 0 and updated in every iteration, by following the risk management process like the one found in figure 1 or figure B.1 of ISO 14971 standard.

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Sunday 17 June 2012

How to combine risk management process with agile software development? - Part 2

This post is the continuation of the post of last week.
We've seen in that post that fixing bugs during software maintenance is like a small chunk of design, excepted that software specifications do not change. Therefore risk management process when fixing bugs is very close to risk management process during design, without the initial assessment of risks at the beginning of the software development cycle.

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Saturday 9 June 2012

How to combine risk management process with agile software development? - Part 1

This post comes after a series of three posts where I exposed my thoughts about development of software medical devices with agile methods.
These posts were focussed on software development. Risk management deserves its own series of posts. Here is the first of three.

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Friday 9 March 2012

Inflation of software medical devices - part 1

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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, private companies have to adhere to these standards. Full stop.
Let's see what these standards are.

General standards

Two ISO standards are of high importance for software medical devices: ISO 13485 and ISO 14971. They can be seen as the topmost standards for medical devices. They are very generic and apply to every medical device, from the simplest plaster to the most complex surgeon robot. As they are so generic, they don’t give a clue about software. Other standards do.

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