Software in Medical Devices, a blog by MD101 Consulting

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Tuesday 16 May 2017

They've raised the bar!

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.

Tuesday 20 December 2016

Cybersecurity in medical devices - Part 2 Stakeholders

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.

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Friday 4 November 2016

Software as a Medical Device (SAMD): clinical evaluation

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.

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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!
http://georgeboole.com

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.

Enjoy!

Thursday 9 July 2015

RIP Elsmar.com

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

Happy New Year 2015!!!

Provence Winter

Sunday 3 August 2014

New theme

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

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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Friday 14 February 2014

How to develop a smartphone App to be FDA-cleared or CE Marked? - part 6 Conclusion

To conclude this series about clearance of mobile medical apps, here are a few tips to newcomers in the world in medical devices.

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Friday 31 January 2014

How to develop a smartphone App to be FDA-cleared or CE Marked? - part 5 Deployment

Back to my blog after a while (you missed me :-)). After the previous article about usability, we're going to see the deployment of mobile medical apps. This article is the last of this series on clearance of mobile medical applications, before conclusion.

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Saturday 28 December 2013

Happy new year 2014

2013 was the year of the confirmation of your interest in my blog. You were 100+ unique visitors per day. A success for a so specific subject!

I thank all of you, who supported my blog by reading the posts and downloading the templates.

Continue reading...

Friday 8 November 2013

14th november 2013 - World Usability Day

If usability is something theoretical for you, I encourage you to have a look at the World Usability Day.

The official theme of this year is: Healthcare: Collaborating for Better Systems

Dozens of events will be hosted by enthusiastic volunteers! Browse events on World Usability Day website. There's probably an event happening close to you.

Friday 27 September 2013

Want to post a medical App on Apple Store? Things get harder!

Apple now asking app developers to provide sources of medical information says imedicalapps.com web site.

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Wednesday 18 September 2013

'Tipping point' for mobile health apps, on BBC News

Here is a record of an interview on BBC News radio.

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Tuesday 10 September 2013

What is Digital Health?

Last week in stumbled upon a video made by Paul Sonnier, head of the Digital Health Group on Linkedin.

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Friday 16 August 2013

2013 Summer break

Summer break. See you at the end of the month with new templates and new articles about hot subjects like mobile apps or software risks management.

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Friday 10 May 2013

When computers prescribe better than doctors

Two computer science researchers of Indiana University have found that predictive algorithms can make better decisions that doctors, reported Indiana University News website.

Continue reading...

Friday 3 May 2013

Interoperability matters, Wireless devices ditto

Today, two publications of the AAMI about interoperability and wireless devices.

The first one is the report of the medical device interoperability summit. The summit was organized in october 2012 by the AAMI and the FDA.
The second one is the report of a workshop about wireless devices in healthcare. It was organized by the AAMI just after the interoperability summit.

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