Software in Medical Devices, a blog by MD101 Consulting

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Wednesday 17 February 2016

Breaking news: standalone software is not an active medical device!

Warning: obsolete content. Please read: Is my software in class I, IIa, IIb or III.
Last update on 2016/07/31.

The British Standard Institute published in February 2016 a white paper titled How to prepare for and implement the upcoming MDR – Dos and don’ts. Register on BSI website to download the paper.
This white paper gives top-notch recommendations on the way to compliance with the future EU Medical Device Regulation (MDR), based on the draft version. But their interpretation of MDR classification rules on standalone software are somewhat surprising.

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Friday 5 February 2016

New FDA draft guidance on interoperable medical devices

The draft guidance about Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices was published late January 2016.

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Friday 29 January 2016

FDA draft guidance on Postmarket Management of Cybersecurity in Medical Devices

The FDA released one week ago a new draft guidance on Postmarket Management of Cybersecurity in Medical Devices.
This guidance is the sister of the guidance on Content of Premarket Submissions for Management of Cybersecurity in Medical Devices released in 2014. Both guidances address cybersecurity at different steps of software lifecycle: the 2014 guidance is about cybersecurity during design and development, the 2016 draft guidance is about cybersecurity during post-market surveillance.

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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 1 January 2016

Happy New Year 2016

Happy New Year 2016 to all of you, readers of this blog! You are now more than 200 unique visitors per day.

Many thanks to all of you.


Friday 18 December 2015

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

The IMDRF published in October 2015 the guidance document titled "Software as a Medical Device (SaMD): Application of Quality Management System" in its final version.

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Saturday 7 November 2015

Happy Birthday Professor Boole

George Boole was born the November 2nd 1815.
The November 2nd 2015 was its bicentenary. He's one of the few scientists whose name became an adjective: boolean.
Happy Birthday Professor Boole!

Thursday 29 October 2015

Essential list of guidances updated

Hi there, The page on essential list of guidances for CE Mark and FDA clearance of software medical devices has been updated.
It contains links to the most recent version of EU and FDA guidances as well as new FDA guidances about mobile apps and cybersecurity.


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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Monday 31 August 2015

New design

Hi all!
CM-DM blog had a lifting, Enjoy the new responsive design!

Friday 28 August 2015

Validation of software used in production and QMS - Part 3 Validation Protocol and Reports

We continue this series on validation of software used in production and QMS with the Validation Protocol and Reports.

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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.

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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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