Explanations on standards, howto's
My own experience on implementation of standards
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Friday 30 January 2015
By Mitch on Friday 30 January 2015, 16:44
To continue with the last article about FDIS IEC 62366-1 standard, let's see now the consequences of this standard on software design.
Friday 9 January 2015
By Mitch on Friday 9 January 2015, 14:16
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.
Friday 22 August 2014
By Mitch on Friday 22 August 2014, 14:12
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.
Friday 8 August 2014
By Mitch on Friday 8 August 2014, 14:03
Thanks to elsmar cove website, we know that the publication of the next version of ISO 13485 is postponed to 2016.
EDIT: elsmar cove forums is dead, see RIP elsmar cove.
Bye bye ISO 13485:2015,
Welcome ISO 13485:2016!
Friday 27 June 2014
By Mitch on Friday 27 June 2014, 11:10
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.
Friday 13 June 2014
By Mitch on Friday 13 June 2014, 10:43
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!
Tuesday 3 December 2013
By Mitch on Tuesday 3 December 2013, 09:41
In the last article we've seen the consequences of regulations on Apps, which run on smartphone or - more broadly - on mobile platforms.
Today, let's have a look at the main standard to apply when developing software for medical devices: IEC 62304, and the context in which most people want to apply it: agile methods.
Friday 5 July 2013
By Mitch on Friday 5 July 2013, 14:00
Friday 28 June 2013
By Mitch on Friday 28 June 2013, 14:28
This is today the last article of this series about SOUP.
SOUP is a concept that we find elsewhere than in the IEC 62304 standard. Namely in the FDA guidances.
Friday 14 June 2013
By Mitch on Friday 14 June 2013, 13:43
After having discussed about open-source software in the last post, we continue today this series about SOUP with the case of standalone software.
Friday 7 June 2013
By Mitch on Friday 7 June 2013, 13:52
After having discussed about frameworks and runtimes in the last article, we continue today this series about SOUP with the case of open-source software.
Friday 31 May 2013
By Mitch on Friday 31 May 2013, 15:06
We saw in the first article of this series, what is a SOUP and what is not a SOUP, according to IEC 62304.
Then we continued in the second article by having a look at OS's and drivers.
Let's now see how to deal with runtimes.
Friday 24 May 2013
By Mitch on Friday 24 May 2013, 14:03
We've seen in the last article, what is a SOUP and what is not a SOUP, according to IEC 62304.
We've also seen that a lot of 3rd party software are SOUPs, to begin with OS, drivers, runtimes, Just-In-Time (JIT) compilers and frameworks.
How to deal with those to be compliant with IEC 62304?
Friday 17 May 2013
By Mitch on Friday 17 May 2013, 14:21
No need to reinvent the wheel when developing software. Everybody uses software made by 3rd parties, to begin with the operating system and general purpose libraries.
IEC 62304 has specific requirements about 3rd party software. What are these requirements and how do they affect software development and maintenance?
Friday 26 April 2013
By Mitch on Friday 26 April 2013, 14:39
Want to see latest news about IEC 62304 2nd Edition?
Have a look at this thread on Elsmar Cove Forum: Update on IEC 62304 revision.
This thread contains an interesting discussion about the topics that are being amended in IEC 62304 by IEC working group:
- Safety classes,
- Legacy software.
Note: for those who don't know Elsmar Cove forum, it's probably the best forum about quality management and standards.
EDIT: elsmar cove forums is dead, see RIP elsmar cove.
Friday 19 April 2013
By Mitch on Friday 19 April 2013, 16:44
The FAQ related to the Implementation of EN 62304 with respect to MDD 93/42/EEC was released by Team NB, the association of Notified Bodies.
You'll find in this FAQ many hot subjects I already mentioned in this blog:
- When software is medical device,
- What is software validation,
- SOUP and legacy software,
- Software risk assessment.
This FAQ shows that the state-of-the-art is still evolving. But I think that it has reached a point of consistency and stability. Many questions in the FAQ hadn't clear answers one or two years back.
Friday 12 April 2013
By Mitch on Friday 12 April 2013, 20:34
In the previous post, we've seen when it's mandatory to be compliant both with IEC 60601-1 and IEC 62304, and when IEC 60601-1 alone is enough.
But some manufacturers don't apply IEC 60601-1, mainly because their devices are not in contact with the patient or cannot be qualified are medical devices. We find in these categories in-vitro diagnosis instruments and laboratory instruments.
These instruments usually fall in the scope of IEC 61010-1. Let's see now the relationship between IEC 61010-1 and IEC 62304.
Friday 5 April 2013
By Mitch on Friday 5 April 2013, 16:50
Manufacturers of medical devices often ask themselves the obvious question:
Is it mandatory to be compliant both with IEC 60601-1 and IEC 62304?
Similarly, manufacturers of in vitro diagnosis devices ask themselves:
Are my devices in the scope of IEC 62304?
Obviously, medical devices (MD) with electric or electronic components are in the scope of IEC 60601-1. And in-vitro diagnosis devices (IVD) with electric or electronic components are in the scope of IEC 61010-1.
Do MD and IVD that embed software, fall in the scope of IEC 62304?
This is not so obvious.
Friday 8 March 2013
By Mitch on Friday 8 March 2013, 14:09
We've seen in the two previous posts several solutions on how to treat legacy software according to IEC 62304.
But there is nothing equivalent to this discussion in IEC 62304. The standard is silent about these situations.
Friday 1 March 2013
By Mitch on Friday 1 March 2013, 14:31
We've seen in the last post how to manage changes in legacy software. Let's see it from another point of view: the type of legacy software.