Software in Medical Devices

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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 10 July 2015

IEC 62304 Amendment 1 published

The new version of IEC 62304, also known as IEC 62304:2015 or amendment 1 of IEC 62304 was published by the IEC at the end of June 2015.
There were no major changes compared to the drafts that were circulated earlier this year.

The two major new requirements, compared to IEC 62304:2006 are:

  • Requirements about legacy software,
  • Changes in the definition of the security classes, based on risk assessment.

IEC 62304:2015 is available on IEC website at the astounding / amazing / appealing / astonishing (delete as appropriate) price of 650 swiss francs (approx. US$700) for the consolidated version.

Now we need to wait for this version to be harmonized by EU and recognized by the USA.

Thursday 9 July 2015


Edit 2016/05/30: Elsmar cove is back! See on

RIP Elsmar Cove Forum.

The forums of people helping people died on June 30th 2015.
It's a great loss for quality assurance and regulatory affairs communities of medical devices, automotive, and many other industries.

More info on reddit.

Marcelo Anthunes, one of the most active moderators of Elsmar Cove, has taken upon himself to create a new Medical Devices Expert Forum. I encourage you to follow the link to this forum, sign-up, and bring your our contribution to this new initiative.

Friday 19 June 2015

Validation of software used in production and QMS - Part 1 introduction

Validation of software is an unlimited source of topics!
After discussing in a previous article the validation of software in development process, let's see how to validate software used in production processes and in the management of QMS documents and records.

Continue reading...

Friday 15 May 2015

IMDRF document: Software as a Medical Device (SaMD): Application of Quality Management System

The International Medical Device Regulators Forum opened a consultation on a draft document about the application of Quality Management System for Software as a Medical Device (SaMD).
The consultation was opened in march and will be closed the 1st of June.

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Friday 24 April 2015

Updates to good old IEC 62304

Georg Heidenreich, one of the author of the Frequently Asked Questions on IEC 62304 published on the Team NB website, posted two weeks ago an article about the upcoming updates in the first amendment of IEC 62304.

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Friday 20 March 2015

When the FDA releases guidances in burst mode

If you watch from time to time the new guidances released by the FDA, you probably noticed that two guidances about software were released in january and february 2015.

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Wednesday 4 March 2015

ISO 13485 201X DIS2

The DIS2 (2nd draft version) of the next ISO 13485 was released in february.
It is published for comments on BSI draft review system website. Go to this website and search for 13485 to have a look at this draft.

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Friday 30 January 2015

IEC/FDIS 62366-1 released in November 2014 - part 2

To continue with the last article about FDIS IEC 62366-1 standard, let's see now the consequences of this standard on software design.

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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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Happy new year 2015

Happy New Year 2015!!!

Provence Winter

Friday 12 December 2014

NBOG’s Best Practice Guide 2014-3: all you wanted to know about reporting software design changes

When should a manufacturer report devices changes or QMS changes to notified bodies, according to the 93/42/CE directive?
There hasn't been clear criteria, until the Notified Bodies Operating Group (NBOG) published the Best Practice Guide 2014-3 : Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System.

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Friday 21 November 2014

Analysis of the FDA Cybersecurity Guidance

At last! The FDA has published last October a guidance about cybersecurity that matters!
Not that the guidance previously published about Off-the-shelf software cybersecurity wasn’t worth reading it (Guidance to Industry: Cybersecurity for Networked Medical Devices Containing Off-the-Shelf Software), but its scope was more than reduced.

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Friday 31 October 2014

Content of DHF, DMR and DHR for medical device software - Part 3 DHR

We continue this series about DHF, DMR and DHR, with the Device History Record.

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Friday 17 October 2014

Content of DHF, DMR and DHR for medical device software - Part 2 DMR

We continue this series about DHF, DMR and DHR, with the Device Master Record.

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Friday 3 October 2014

Content of DHF, DMR and DHR for medical device software - Part 1 DHF

After a temporary absence, I'm back on the waves with a new series of articles to talk about the files required by the 21 CFR 820 regulations:

  • DHF: Design History File,
  • DMR: Device Master Record,
  • DHR: Device History Record.

Let's begin with the DHF.

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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 8 August 2014

Next version of ISO 13485 postponed to 2016

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!

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Sunday 3 August 2014

New theme


If you follow regularly this blog, you noticed that there was not much new the last three weeks.
I had other commitments and took my remaining time to do a bit of admin on this blog to make it clean and up-to-date.
I've also changed the theme!
If you like it or not, you're welcomed to add a comment below.

I use a simple and free filter to discard junk comments. There are too many remaining junk comments so all comments are moderated. Then I publish manually those that are from real humans!
If you leave a comment, you'll need a bit time until a publish it. I apologize for the delay.

Friday 11 July 2014

New FDA Draft Guidance on MDDS

The FDA released on june 20th 2014 a new draft guidance about:

  • Medical Devices Data Systems (MDDS) subject to 21 CFR 880.6310,
  • Medical image storage devices subject to 21 CFR 892.2010, and
  • Medical image communications devices subject to 21 CFR 892.2020.

Link to FDA MDDS draft guidance: EDIT - draft guidance superseded by final guidance, see this post

Continue reading...

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