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The FDA released on june 20th 2014 a new draft guidance about: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Link to FDA MDDS draft guidance: EDIT - draft guidance superseded by final guidance, see this post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!
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
Friday 12 July 2013
By Mitch on Friday 12 July 2013, 14:33
Unique Device Identification (UDI) had been in the pipes of regulators for a few years, beginning with the US in 2007, and following (as usual) by the European Union a few years later in 2012.
In parallel, the International Medical Device Regulators Forum (IMDRF) issued in 2011 a guidance on UDI, with the honorable objective of harmonizing UDI's all over the world.
What is the impact of these regulations and guidances on medical device software?
Friday 21 June 2013
By Mitch on Friday 21 June 2013, 13:02
Interrupting our series about IEC 62304 SOUP, we have breaking news from the FDA!
The FDA published this month a new Draft Guidance about Cyber Security and released a Safety Communication about Cybersecurity for Medical Devices and HospitalNetworks .
The federal agency recommends that manufacturers review their cybersecurity practices and policies to assure that appropriate safeguards are in place to prevent unauthorized access or modification to their medical devices. In other words, hacking treats, network intrusions, and the like, have to be addresses in the software risk assessment report.
Bouncing back to our series about SOUP, such risks shall be assessed when a SOUP is integrated in your software.
Friday 22 March 2013
By Mitch on Friday 22 March 2013, 11:59
A few words about guidances in Europe. News are rare enough to point them out.
First, the guidance on electronic labelling came into force on 1st march 2013, see the MHRA website for some explanations and the original decision on the EU website.
Friday 8 February 2013
By Mitch on Friday 8 February 2013, 14:41
The AAMI TIR45:2012, Guidance on the use of AGILE practices in the development of medical device software enters in the list of recognized standards by the FDA. See here on Federal Register website.