Here is a record of an interview on BBC News radio.
Wednesday, 18 September 2013
'Tipping point' for mobile health apps, on BBC News
By Mitch on Wednesday, 18 September 2013, 13:57 - Misc
Friday, 13 September 2013
Templates STP - STD and STR updated
By Mitch on Friday, 13 September 2013, 13:22 - Templates
Here is an update of Software Test Plan, Software Test Description, and Software Test Report templates.
Tuesday, 10 September 2013
What is Digital Health?
By Mitch on Tuesday, 10 September 2013, 13:28 - Misc
Last week in stumbled upon a video made by Paul Sonnier, head of the Digital Health Group on Linkedin.
Friday, 6 September 2013
Templates SAD and SDD updated
By Mitch on Friday, 6 September 2013, 13:21 - Templates
Here is an update of System Architecture Description template and Software Detailed Design template.
Friday, 30 August 2013
Template SRS updated
By Mitch on Friday, 30 August 2013, 13:45 - Templates
Here is an update of Software Requirements Specifications template.
Friday, 16 August 2013
2013 Summer break
By Mitch on Friday, 16 August 2013, 13:46 - Misc
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.
Friday, 9 August 2013
FDA recognizes 25 standards about IT risk management, interoperability and cybersecurity
By Mitch on Friday, 9 August 2013, 14:25 - Regulations
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
FDA Mobile Medical App Guidances should be released by the end of the year
By Mitch on Friday, 2 August 2013, 11:12 - Regulations
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
IMDRF published a proposed document on standalone software definitions
By Mitch on Saturday, 27 July 2013, 09:58 - Regulations
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
Unique Device Identification for software medical device - part 2
By Mitch on Friday, 19 July 2013, 13:50 - Regulations
This is the second part of our discussion about Unique Device Identification (UDI).
Friday, 12 July 2013
Unique Device Identification for software medical device - part 1
By Mitch on Friday, 12 July 2013, 14:33 - Regulations
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, 5 July 2013
Got SOUP? - Further Reading
By Mitch on Friday, 5 July 2013, 14:00 - Standards
Further reading to complete this long series about SOUP:
You can have a look at this excellent article about OTS/SOUP validation strategies.
Next week, we'll see Unique Device Identification (UDI) for software.
Friday, 28 June 2013
Got SOUP? - Part 6 - FDA Guidance and Conclusion
By Mitch on Friday, 28 June 2013, 14:28 - Standards
This is today the last article of this series about SOUP.
SOUP is a concept that we find elsewhere than in the IEC 62304 standard. Namely in the FDA guidances.
Friday, 21 June 2013
New FDA Cyber Security Draft Guidance
By Mitch on Friday, 21 June 2013, 13:02 - Regulations
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, 14 June 2013
Got SOUP? - Part 5 - Standalone software
By Mitch on Friday, 14 June 2013, 13:43 - Standards
After having discussed about open-source software in the last post, we continue today this series about SOUP with the case of standalone software.
Friday, 7 June 2013
Got SOUP? - Part 4 - Open-Source Software
By Mitch on Friday, 7 June 2013, 13:52 - Standards
After having discussed about frameworks and runtimes in the last article, we continue today this series about SOUP with the case of open-source software.
Friday, 31 May 2013
Got SOUP? - Part 3 - Runtimes, Frameworks
By Mitch on Friday, 31 May 2013, 15:06 - Standards
We saw in the first article of this series, what is a SOUP and what is not a SOUP, according to IEC 62304.
Then we continued in the second article by having a look at OS's and drivers.
Let's now see how to deal with runtimes.
Friday, 24 May 2013
Got SOUP? - Part 2 - OS, Drivers, Runtimes
By Mitch on Friday, 24 May 2013, 14:03 - Standards
We've seen in the last article, what is a SOUP and what is not a SOUP, according to IEC 62304.
We've also seen that a lot of 3rd party software are SOUPs, to begin with OS, drivers, runtimes, Just-In-Time (JIT) compilers and frameworks.
How to deal with those to be compliant with IEC 62304?
Friday, 17 May 2013
Got SOUP? - Part 1 - Because every good software starts with SOUP
By Mitch on Friday, 17 May 2013, 14:21 - Standards
No need to reinvent the wheel when developing software. Everybody uses software made by 3rd parties, to begin with the operating system and general purpose libraries.
IEC 62304 has specific requirements about 3rd party software. What are these requirements and how do they affect software development and maintenance?
Friday, 10 May 2013
When computers prescribe better than doctors
By Mitch on Friday, 10 May 2013, 14:37 - Misc
Two computer science researchers of Indiana University have found that predictive algorithms can make better decisions that doctors, reported Indiana University News website.
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