Saturday 27 July 2013
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
By Mitch on Friday 19 July 2013, 13:50 - Regulations
Friday 12 July 2013
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
By Mitch on Friday 5 July 2013, 14:00 - Standards
Friday 28 June 2013
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
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The FDA published this month a new Draft Guidance about Cyber Security and released a Safety Communication about Cybersecurity for Medical Devices and HospitalNetworks .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
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
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
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
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
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
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
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
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,
- Legacy software.
Note: for those who don't know Elsmar Cove forum, it's probably the best forum about quality management and standards.
Friday 19 April 2013
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.
Friday 12 April 2013
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
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
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
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
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.