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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...
View ArticleIEC/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.Software GUI evaluationIn software, humans factors engineering is...
View ArticleISO 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...
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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.We have the :Medical Device Data...
View ArticleUpdates 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...
View ArticleIMDRF document: Software as a Medical Device (SaMD): Application of Quality...
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...
View ArticleValidation 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...
View ArticleRIP Elsmar.com
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...
View ArticleIEC 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...
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Validation of software used in production and QMS - Part 2 Validation Master...
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...
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Validation of software used in production and QMS - Part 3 Validation...
We continue this series on validation of software used in production and QMS with the Validation Protocol and Reports.The Validation Master Plan (VMP) comes with other documents:The Validation Master...
View ArticleIEC 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...
View ArticleEssential 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...
View ArticleHappy 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...
View ArticleIMDRF final document: Software as a Medical Device (SaMD): Application of...
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.The draft version was published in...
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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.
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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...
View ArticleFDA 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...
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