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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:
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
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:
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
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.
Friday, 8 March 2013
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.
Friday, 1 March 2013
By Mitch on Friday, 1 March 2013, 14:31 - Standards
We've seen in the last post how to manage changes in legacy software. Let's see it from another point of view: the type of legacy software.
Friday, 22 February 2013
By Mitch on Friday, 22 February 2013, 14:09 - Standards
Most of medical devices manufacturers have legacy software that was not designed according to IEC 62304. The devices that embed legacy software were once verified and validated. These devices and their software work well and no major adverse event were raised by software issues.
But one day, the manufacturer decides that it's time to bring that legacy software into line with IEC 62304, to align the technical file of that software (or the contribution of software to technical file content) with up-to-date standard or regulatory requirements.
Friday, 15 February 2013
By Mitch on Friday, 15 February 2013, 14:00 - Misc
Innovations in the field of medical devices are highly influenced by technologies like nano-sensors, bio-MEMS, and mobile platforms.
In this kind of devices, wearable sensors are emerging as the next must-have. Wearable sensors are tiny gadgets that you have permanently with you, hidden in your clothes or in a piece of jewelry. They monitor vital (or non-vital) signs like arterial pulse and transmit data to local computers or remote platforms. Data are analyzed on the receiver to control anything you want: high blood pressure...
Early adopters of such devices will surely be geeks or techno-victims, but we can bet in a few years everybody will have at least one.
A good example is the Shine by Misfits Wearables. It's a concentrate of technology that monitors body parameters and communicates with your smartphone. And it's a deliberately nice object!
For me it's also a concentrate of all buzzwords heard in innovative medical devices!
We don't know yet wether such objects will become truly useful medical devices or will remain gadgets. Wether they will change or not our habits, like smartphones did. That's the role of the market (doctors and the public) to say so.
Friday, 8 February 2013
By Mitch on Friday, 8 February 2013, 14:41 - Regulations
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.
Friday, 1 February 2013
By Mitch on Friday, 1 February 2013, 14:02 - Regulations
Too busy to write a long post this week.
I've not talked about a new FDA draft guidance yet:
The Draft Guidance for Industry and FDA Staff - Design Considerations for Devices Intended for Home Use.
Though not specific to software, this guidance has consequences on software design of medical devices for home use. The design team has to watch for problems linked to the users, their diseases and their environment where things can get messy.
Most of the content of that guidance is not intended to be applied specifically to software. But it contains a few elements that are applicable to software, mainly alarms, human factors, and use of device in emergency. That is another way of saying that ergonomics and human factors engineering are important input data for software development.
Monday, 21 January 2013
By Mitch on Monday, 21 January 2013, 15:34 - Standards
In the last two posts, we've seen what a software unit is, and when to do software detailed design, according to IEC 62304 and FDA Guidances.
Friday, 18 January 2013
By Mitch on Friday, 18 January 2013, 15:45 - Standards
In my last post, I explained what criteria should be taken to define the level of details of software units in a software design. This activity is not mandatory for all levels of risk of software in medical devices, though, according to IEC 62304.
Friday, 11 January 2013
By Mitch on Friday, 11 January 2013, 14:08 - Standards
IEC 62304 requires to split architecture of class C (mission critical) software into software items and software units. Software units are software items that can't be split into sub-items, according to the standard. Okay. But how to decide that an item can't be split into sub-items, and is a unit?
Friday, 4 January 2013
By Mitch on Friday, 4 January 2013, 12:10 - Misc
The Internet of Things is probably the next step of the networking of our everyday life.
The web 1.0 was the era where websites were only read-only, with very little interaction.
The web 2.0 is the web of today, with social networks and heavy interaction between web users.
We don't know yet what the web 3.0 will be. But the interaction between networked objects and between networked people and networked objects is perhaps one facet of the web of the future.
Friday, 28 December 2012
By Mitch on Friday, 28 December 2012, 13:47 - Misc
If you want to know how to have a 21 CFR Part 11 compliant system, have a look at Daniel Riganati's blog:
http://riganati.blogspot.fr/2012/06/validation-its-more-than-just-testing.html
It's damned well explained! Congrats Daniel!
This blog is alive since september 2011. I began with very few readers (3 per day including my family :)
Now I have 100 unique visitors per day. You break through the threshold this month in december.
You all made me a nice present at the end of 2012!
I want to thank you all and wish you an happy new year.
Happy new year
Feliz Año nuevo
Bonne Année
Frohes neues Yahr
Friday, 21 December 2012
By Mitch on Friday, 21 December 2012, 12:59 - Misc
We all use Wifi in our everyday life. When we don't have it, we growl and yowl. When we have to use a good old RJ45 network cable, we feel like a dog on a leash.
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