Friday 22 July 2016
By Mitch on Friday 22 July 2016, 13:28
The final version of the negotiated text of the new Medical Device Regulation (MDR) was published by the European Commission in June 2016. It is a big upheaval for all medical device manufacturers. Contrary to what the draft version of September 2015 contained, software is invited to the party.
Wednesday 17 February 2016
By Mitch on Wednesday 17 February 2016, 10:13
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.
Friday 5 February 2016
By Mitch on Friday 5 February 2016, 13:45
Friday 29 January 2016
By Mitch on Friday 29 January 2016, 14:30
The FDA released one week ago a new draft guidance on Postmarket Management of Cybersecurity in Medical Devices.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different steps of software lifecycle: the 2014 guidance is about cybersecurity during design and development, the 2016 draft guidance is about cybersecurity during post-market surveillance.
Friday 28 August 2015
By Mitch on Friday 28 August 2015, 12:54
We continue this series on validation of software used in production and QMS with the Validation Protocol and Reports.
Friday 24 July 2015
By Mitch on Friday 24 July 2015, 11:57
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.
Friday 15 May 2015
By Mitch on Friday 15 May 2015, 15:34
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.
Friday 20 March 2015
By Mitch on Friday 20 March 2015, 17:03
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.
Friday 12 December 2014
By Mitch on Friday 12 December 2014, 21:42
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.
Friday 21 November 2014
By Mitch on Friday 21 November 2014, 12:46
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.
Friday 31 October 2014
By Mitch on Friday 31 October 2014, 12:48
We continue this series about DHF, DMR and DHR, with the Device History Record.
Friday 17 October 2014
By Mitch on Friday 17 October 2014, 12:44
We continue this series about DHF, DMR and DHR, with the Device Master Record.
Friday 3 October 2014
By Mitch on Friday 3 October 2014, 13:58
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.
Friday 11 July 2014
By Mitch on Friday 11 July 2014, 22:34
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
Monday 12 May 2014
By Mitch on Monday 12 May 2014, 07:40
MHRA, the regulatory authority of the UK, published in march a guidance on medical device standalone software.
This guidance is a prime source of information about software in medical devices in the European Union. It gathers all existing information about the way medical device software is regulated in the EU.
Friday 17 January 2014
By Mitch on Friday 17 January 2014, 12:36
In the last article, we saw the concerns about the reliability of wireless connections and how to handle them.
Today, we are going to have a look at something quite important for mobile platforms: usability and humans factors engineering (HFE).
Friday 3 January 2014
By Mitch on Friday 3 January 2014, 12:34
In the last article, we explained why agile methods are so popular for mobile app software development. Today, we are going to review a major characteristic of mobile platforms: wireless connection.
Friday 15 November 2013
By Mitch on Friday 15 November 2013, 13:51
Today I begin a new series of articles about developing (or more broadly designing) a smartphone App that is a medical device.
The very first question is:
Is your App a medical device and does it need to be CE Marked or FDA cleared ?
Friday 1 November 2013
By Mitch on Friday 1 November 2013, 09:48
The last time I updated my essential list of guidances was in 2012. Today I've done a full refresh of that page with:
- Change of GHTF to IMDRF,
- Update of links to TEAM-NB website,
- Update of FDA guidances, especially the brand new guidance about mobile medical applications.
I hope you'll find all relevant regulatory information about software on that essential list of guidances.
Wednesday 25 September 2013
By Mitch on Wednesday 25 September 2013, 17:28
After two years of gestation, FDA issues final Guidance on Mobile Medical Apps!