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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:
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:
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.
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:
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!
Friday, 9 August 2013
By Mitch on Friday, 9 August 2013, 14:25
FDA recognizes 25 standards about risk management, interoperability and cybersecurity.
More on AAMI news website and the link to the Federal Register notice of Aug 6, 2013.
Friday, 2 August 2013
By Mitch on Friday, 2 August 2013, 11:12
To continue the topic about FDA draft guidances related to software and information systems, the FDA put in its top list the release of the Guidance of Mobile Medical Apps.
Guidance of Mobile Medical Apps is in the "A-list" of FDA and should be released by the end of 2013.
In hot topics, we have also a warning letter sent by the FDA to Biosense Technologies. The mobile App named uChek Urine Analyzer and developed by Biosense Technologies, falls into the category of medical devices, says FDA. Biosense claims on its website that the App turns the smartphone into a medical lab.
With such claim, it's not surprising that the FDA wants Biosense to submit a 510k!
Saturday, 27 July 2013
By Mitch on Saturday, 27 July 2013, 09:58
At be beginning of june 2013, the International Medical Devices Regulators Forum (IMDRF) published a proposed document on standalone software definitions.
The goal of this document is to harmonize the key definitions related to standalone software.
Friday, 19 July 2013
By Mitch on Friday, 19 July 2013, 13:50
This is the second part of our discussion about Unique Device Identification (UDI).
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