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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 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 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 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 13 July 2012
By Mitch on Friday 13 July 2012, 15:04 - Misc
Happtique, an appstore for mobile medical devices has drafted an
App Certification Program.
This not a program or a process but a list of functional and non functional
requirements that mobile health apps should respect to be certified - according
to Happtique. It' a bit like the requirements of Apple to be authorized to
place an app in the Apple Store. Happtique publishes your app on its store if
you are compliant with its certification program.
There is a lot of work behind this document, and a lot of knowledge. However I
don't think this is enough to make a certification program. This document
focuses on the results, whereas all software development standards focus on the
processes. FDA focuses also on the processes when its auditors verify
compliance to 21.CFR.
In the scale of precedence of documents, I would put it here:
It's obvious that Happtique wants to make some noise with its certification
program (and it has reached his goal, you're reading this post). But I have to
recognize that this document contains a big source of information for software
requirements. The content of this certification program is a perfect source of
ideas to write a software requirements specification (SRS).
The world of mHealth is moving fast. In the same kind of article, I have found
Tech
Barbarians at the Medtech Gates, this article is a good summary of
antagonist forces at stake. On the one hand, the regulators and their, so
called, ante-Flood rules. On the other hand, the software industry with its new
world of mHealth. Guess who's going to have the last word? If, like me, you
don't have the answer, continue to apply the standards and regulations...
Bye.
Friday 30 March 2012
By Mitch on Friday 30 March 2012, 10:51 - Regulations
Today I’m going to talk about the inflation to regulations in the world of software for medical devices. In my previous post, I had a look at the inflation of standards for medical devices. As the medical devices industry is heavily controlled by regulations, they deserve a dedicated post.
Wednesday 22 February 2012
By Mitch on Wednesday 22 February 2012, 09:21 - Regulations
Too many documents in too many places, that’s what I felt the first time I
looked for guidances and other similar stuff about software medical
devices.
Where do I find relevant documents?
Which one do I begin with?
My answer:
I created a page where I gather my own list of guidances. It’s a selection of
guidances and recommendations for CE mark.
Hope you enjoy it :-)
Monday 6 February 2012
By Mitch on Monday 6 February 2012, 18:14 - Regulations
New! MEDDEV 2.1/6 Guidelines on classification of standalone software released!
HIS, CIS, PDMS, RIS, PACS, LIMS … Which ones are medical devices, which ones are not?
To answer this question, the European Commission issued a new Guidelines document: MEDDEV 2.1/6, about the qualification and classification of standalone software as Medical Devices or In Vitro Diagnosis Devices.
Download here
After the draft guidance of the FDA about mobile apps, after the guide on regulation of health apps by a UK medical charity, this MEDEV is the third document released in a few months about standalone software.
Monday 28 November 2011
By Mitch on Monday 28 November 2011, 17:19 - Regulations
The GHTF (Global Harmonization Task Force) issued a draft of a new guidance on medical device classification They recommend to implement four classes for medical devices based on intended use: from class A (lowest risk) to class D (highest risk). And they give a set of rules on how to choose the classification of the devices.
Wait, I've already seen this elsewhere. Classification of devices in Europe (CE mark) and in Canada have systems very similar to what GHTF recommends. This is a good thing to have an ongoing harmonization process. National regulations copy what GHTF recommends and GHTF copies what national regulations require. This is a virtuous circle. Maybe one day the FDA will implement this classification system.