Will it take more time than the age of the universe?
Thursday, 28 September 2023
Time it takes an evaluator to review your tech file in 2023
By Mitch on Thursday, 28 September 2023, 18:02
Misc
Monday, 5 December 2022
Letter to EPSCO for their meeting of the 9th December 2022
By Mitch on Monday, 5 December 2022, 11:47
Hi EPSCO!
I hope you’re doing well!
We’re a bit concerned by your mindset, it looks like you don’t know where you have to go at your meeting of the 9th December.
Please find below some suggestions just for you.
Tuesday, 14 June 2022
MDCG 2022-11 - Monty Python and the Holy Grail
By Mitch on Tuesday, 14 June 2022, 21:41
Have you seen the MDCG 2022-11 - MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements?
Friday, 22 April 2022
New SaMD Classification scheme
By Mitch on Friday, 22 April 2022, 14:20
A new unofficial SaMD classification scheme. Will it be adopted with the postponement of the MDR?
Saturday, 6 November 2021
Ten years
By Mitch on Saturday, 6 November 2021, 16:18
This blog is ten years old!
Thank you to all of you who read, download and share the content of this blog.
Keep goin'
Friday, 26 March 2021
When Web meets SOUP
By Mitch on Friday, 26 March 2021, 13:38
The definition of SOUP, and the requirements related to their lifecycle in IEC 62304 processes, are totally independent of any technology. Making no technological assumption, that's the way the standard is thought, so that it can be applied to any health software.
Cloud-based applications and web technologies make an intensive use of SOUPs. Let's see how IEC 62304 requirements can be applied to these technologies.
Saturday, 18 April 2020
If the European Commission claimed ISO 13485 conformity
By Mitch on Saturday, 18 April 2020, 12:03
Having struggled with dozens of software editors who wanted to CE mark their class I software before May 2020. Having struggled with the lockdown, having struggled with projects in war mode to fight against the Covid-19, here I am! My last post was in December 2019, too long to make an active blog.
Today I post an article with a tone of speech a bit different than usual. No software, no comment on regulatory guidances. Probably an effect of the current situation, which affects all of us.
Friday, 25 October 2019
User stories or software requirements?
By Mitch on Friday, 25 October 2019, 21:24
I frequently have the following discussion with software development teams: can user stories be taken as software requirements? The answer is yes or no. All cases can be found in nature!
Sunday, 7 January 2018
Happy New Year 2018
By Mitch on Sunday, 7 January 2018, 16:52
Happy New Year 2018!
Thanks for still visiting this blog, despite the spaced updates!
Tuesday, 16 May 2017
They've raised the bar!
By Mitch on Tuesday, 16 May 2017, 22:34
If you are a regular visitor of this blog, you noticed that almost three months elapsed between the last two articles on cybersecurity.
That's not what I planned.
The time dedicated to this blog was totally swallowed by the other facets of my job. Namely filling the gap between the current level of compliance of manufacturers, and the new expectations of notified bodies and regulatory authorities in the European Union. The bar has been raised!
It gives you a sense of what we're getting into with the new MDR.
Monday, 2 January 2017
Happy New Year 2017
By Mitch on Monday, 2 January 2017, 23:04
Happy New Year!
Thank-you for your loyalty!
Tuesday, 20 December 2016
Cybersecurity in medical devices - Part 2 Stakeholders
By Mitch on Tuesday, 20 December 2016, 12:51
After a long interruption, we continue this series on cybersecurity in medical devices with a review of stakeholders involved or concerned by cybersecurity requirements, and the consequences on architectural choices.
Friday, 4 November 2016
Software as a Medical Device (SAMD): clinical evaluation
By Mitch on Friday, 4 November 2016, 15:37
The FDA released a guidance on clinical evaluation of standalone software medical device (a.k.a SAMD) in October 2016. This guidance is the same text and has the same presentation as the International Medical Device Regulatory Forum (IMDRF) guidance on SAMD clinical evaluation published in August 2016.
Friday, 18 December 2015
IMDRF final document: Software as a Medical Device (SaMD): Application of Quality Management System
By Mitch on Friday, 18 December 2015, 15:33
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.
Saturday, 7 November 2015
Happy Birthday Professor Boole
By Mitch on Saturday, 7 November 2015, 10:33
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!
http://georgeboole.com
Thursday, 29 October 2015
Essential list of guidances updated
By Mitch on Thursday, 29 October 2015, 17:10
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.
Enjoy!
Thursday, 9 July 2015
RIP Elsmar.com
By Mitch on Thursday, 9 July 2015, 17:24
Edit 2016/05/30: Elsmar cove is back! See on 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 other industries.
More info on reddit.
Fortunately:
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, 9 January 2015
Happy new year 2015
By Mitch on Friday, 9 January 2015, 14:00
Happy New Year 2015!!!
Sunday, 3 August 2014
New theme
By Mitch on Sunday, 3 August 2014, 23:55
Hello!
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.
Note:
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.
Monday, 26 May 2014
IMDRF consultation: Software as a Medical Device
By Mitch on Monday, 26 May 2014, 00:02
After MHRA's guidance on standalone software, we continue with another official document published by the International Medical Device Regulators Forum (IMDRF): the consultation on software as a medical device: Possible Framework for Risk Categorization and Corresponding Controls.
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