This is the second part of our discussion about Unique Device Identification (UDI).
Friday, 19 July 2013
Unique Device Identification for software medical device - part 2
By Mitch on Friday, 19 July 2013, 13:50 - Regulations
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New FDA Cyber Security Draft Guidance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The FDA published this month a new Draft Guidance about Cyber Security and released a Safety Communication about Cybersecurity for Medical Devices and HospitalNetworks .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.
Friday, 3 May 2013
Interoperability matters, Wireless devices ditto
By Mitch on Friday, 3 May 2013, 14:38 - Misc
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.
Friday, 26 April 2013
Latest news about IEC 62304 2nd Edition
By Mitch on Friday, 26 April 2013, 14:39 - Standards
Want to see latest news about IEC 62304 2nd Edition?
Have a look at this thread on Elsmar Cove Forum: Update on IEC 62304 revision.
This thread contains an interesting discussion about the topics that are being amended in IEC 62304 by IEC working group:
- Safety classes,
- SOUP,
- Legacy software.
Enjoy.
Note: for those who don't know Elsmar Cove forum, it's probably the best forum about quality management and standards.
EDIT: elsmar cove forums is dead, see RIP elsmar cove.
Friday, 19 April 2013
FAQ related to the Implementation of EN 62304 published by TEAM-NB
By Mitch on Friday, 19 April 2013, 16:44 - Standards
The FAQ related to the Implementation of EN 62304 with respect to MDD 93/42/EEC was released by Team NB, the association of Notified Bodies.
You'll find in this FAQ many hot subjects I already mentioned in this blog:
- When software is medical device,
- What is software validation,
- SOUP and legacy software,
- Software risk assessment.
This FAQ shows that the state-of-the-art is still evolving. But I think that it has reached a point of consistency and stability. Many questions in the FAQ hadn't clear answers one or two years back.
Keep going!
Friday, 12 April 2013
MD and IVD standards: IEC 60601-1 and IEC 61010-1, versus IEC 62304 - Part 2
By Mitch on Friday, 12 April 2013, 20:34 - Standards
In the previous post, we've seen when it's mandatory to be compliant both with IEC 60601-1 and IEC 62304, and when IEC 60601-1 alone is enough.
But some manufacturers don't apply IEC 60601-1, mainly because their devices are not in contact with the patient or cannot be qualified are medical devices. We find in these categories in-vitro diagnosis instruments and laboratory instruments.
These instruments usually fall in the scope of IEC 61010-1. Let's see now the relationship between IEC 61010-1 and IEC 62304.
Friday, 5 April 2013
MD and IVD standards: IEC 60601-1 and IEC 61010-1, versus IEC 62304 - Part 1
By Mitch on Friday, 5 April 2013, 16:50 - Standards
Manufacturers of medical devices often ask themselves the obvious question:
Is it mandatory to be compliant both with IEC 60601-1 and IEC 62304?
Similarly, manufacturers of in vitro diagnosis devices ask themselves:
Are my devices in the scope of IEC 62304?
Obviously, medical devices (MD) with electric or electronic components are in the scope of IEC 60601-1. And in-vitro diagnosis devices (IVD) with electric or electronic components are in the scope of IEC 61010-1.
Do MD and IVD that embed software, fall in the scope of IEC 62304?
This is not so obvious.
Friday, 29 March 2013
Brain Computer Interface - the future of healthcare
By Mitch on Friday, 29 March 2013, 14:02 - Misc
Brain Computer Interface is the term used for a very advanced kind of man machine interface. They allow to send orders to a machine through thought. Sensors are directly connected to the brain of the user and a computer interpret the neural signals to transform them in orders.
Friday, 22 March 2013
EU Guidances - What's new?
By Mitch on Friday, 22 March 2013, 11:59 - Regulations
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, 15 March 2013
Yet another man machine interface
By Mitch on Friday, 15 March 2013, 13:48 - Misc
Until the early 2000's, the mouse used to rule as absolute king over other man machine interfaces.
Since then, touchpads, touchscreens, touchless peripherals like the kinect and other devices have appeared and conquered large territories of mouse kingdom.
Friday, 8 March 2013
How to bring legacy software into line with IEC 62304? - part 3
By Mitch on Friday, 8 March 2013, 14:09 - Standards
We've seen in the two previous posts several solutions on how to treat legacy software according to IEC 62304.
But there is nothing equivalent to this discussion in IEC 62304. The standard is silent about these situations.
« previous entries - page 9 of 13 - next entries »
