Software in Medical Devices, a blog by MD101 Consulting

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Standards

Explanations on standards, howto's

My own experience on implementation of standards

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Friday 28 June 2013

Got SOUP? - Part 6 - FDA Guidance and Conclusion

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.

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Friday 14 June 2013

Got SOUP? - Part 5 - Standalone software

After having discussed about open-source software in the last post, we continue today this series about SOUP with the case of standalone software.

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Friday 7 June 2013

Got SOUP? - Part 4 - Open-Source Software

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.

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Friday 31 May 2013

Got SOUP? - Part 3 - Runtimes, Frameworks

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.

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Friday 24 May 2013

Got SOUP? - Part 2 - OS, Drivers, Runtimes

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?

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Friday 17 May 2013

Got SOUP? - Part 1 - Because every good software starts with SOUP

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?

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Friday 26 April 2013

Latest news about IEC 62304 2nd Edition

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,
  • SOUP,
  • Legacy software.

Enjoy.

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

FAQ related to the Implementation of EN 62304 published by TEAM-NB

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.

Keep going!

Friday 12 April 2013

MD and IVD standards: IEC 60601-1 and IEC 61010-1, versus IEC 62304 - Part 2

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.

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Friday 5 April 2013

MD and IVD standards: IEC 60601-1 and IEC 61010-1, versus IEC 62304 - Part 1

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.

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Friday 8 March 2013

How to bring legacy software into line with IEC 62304? - part 3

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.

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Friday 1 March 2013

How to bring legacy software into line with IEC 62304? - part 2

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.

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Friday 22 February 2013

How to bring legacy software into line with IEC 62304? - part 1

Most of medical devices manufacturers have legacy software that was not designed according to IEC 62304. The devices that embed legacy software were once verified and validated. These devices and their software work well and no major adverse event were raised by software issues.
But one day, the manufacturer decides that it's time to bring that legacy software into line with IEC 62304, to align the technical file of that software (or the contribution of software to technical file content) with up-to-date standard or regulatory requirements.

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Monday 21 January 2013

Class A, B and C. Is it possible to reduce the documentation of detailed design of software medical devices?

In the last two posts, we've seen what a software unit is, and when to do software detailed design, according to IEC 62304 and FDA Guidances.

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Friday 18 January 2013

Class A, B and C. When to do detailed design of software medical devices?

In my last post, I explained what criteria should be taken to define the level of details of software units in a software design. This activity is not mandatory for all levels of risk of software in medical devices, though, according to IEC 62304.

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Friday 11 January 2013

What is a Software Unit?

IEC 62304 requires to split architecture of class C (mission critical) software into software items and software units. Software units are software items that can't be split into sub-items, according to the standard. Okay. But how to decide that an item can't be split into sub-items, and is a unit?

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Friday 19 October 2012

How to deal with ISO 14971 in a software company?

Let's continue a former post about dealing with ISO 13485 in a software company. ISO 13485 and ISO 14971 are a bit like sister standards. You can't implement one without the other!
But how to deal with ISO 14971 in a software company, actually?

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Friday 11 May 2012

How to deal with ISO 13485 in a software company?

Reading the ISO 13485 standard doesn't helped me knowing how to manage the lifecycle of software medical devices. The QMS of a software company has to be adapted to be in conformity with ISO 13485.

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Saturday 14 April 2012

Is my software in class A, B or C?

IEC 62304 defines three safety classes for software:

  • Class A: No injury or damage to health is possible
  • Class B: Non-SERIOUS INJURY is possible
  • Class C: Death or SERIOUS INJURY is possible

Here comes the eternal question: Which class my software belongs to?

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Friday 9 March 2012

Inflation of software medical devices - part 1

the-lesson.jpg
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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