Friday 18 November 2011
By Mitch on Friday 18 November 2011, 18:10 - Standards
The homologation of a medical device is a complex task and can become a nightmare with devices with a high level of risk. It involves many standards and regulations, different from one country to another: FDA in the USA, CE Mark in Europe, CMDCAS in Canada, KFDA in South Korea, and so on …
Fortunately, most of these regulations have common requirements and rely on ISO standards, the most important standards being ISO 13485 and ISO 14971. If you meet the requirements of these standards, you increase your chances of passing the homologations for the devices with low risk. For devices with high risk, these standards are (almost) mandatory.
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Monday 14 November 2011
By Mitch on Monday 14 November 2011, 10:32 - Regulations
The boom of mobile apps on smart phones clearly impacts the medical devices
industry. Doctors are eager to have the last software gadget (the app) on their
hardware gadget (the smartphone, the tablet). As a result, many apps on
Apple Store and Android Store fall into the scope of medical devices:
terminal to remotely display medical images, apps to compute doses of
medicines, an so on ... The list is long.
And gess what? These apps shall be certified before being put in the
Apple-Android stores. The FDA is clear about these "mobile medical apps" in a
draft guidance published in july 2011: "For the subset of mobile medical apps
that are subject to regulatory oversight, manufacturers must meet the
requirements associated with the applicable device classification." see the
Draft Guidance. For the CE mark, the rule is the same, mobile medical apps
fall into the category of active medical devices.
The big family of medical devices is getting more and more children. Welcome
to the baby smartphone apps!
Friday 11 November 2011
By Mitch on Friday 11 November 2011, 15:30 - Templates
Here is the Project Management Plan
Template.
This template doesn't contain anything technical. Has it something to do
with software development? Yes, it has. It contains all the answers to
questions like: Who, What, Where, When, How, Why and How much? You can
do all the technical stuff you want, but without a minimum of organisation,
your software will never be certified. This template deals with
sections of IEC 62304 about project organisation. Use it to answer to those
requirements of the standard.
Please, fell free to give me feedback on my e-mail contact@cm-dm.com
I share this template with the conditions of CC-BY-NC-ND license.
This work is licensed under a
Creative Commons
Attribution-NonCommercial-NoDerivs 3.0 France License.
Wednesday 9 November 2011
By Mitch on Wednesday 9 November 2011, 22:58 - Templates
This template is useful for people addicted to extreme programming: Design consolidation
document.
Reviewers are not confortable with iterative processes. When you look at
recognized standards for soft development, like IEC 62304, you can see that
they are stuck to the waterfall process. Extreme programming isn't their cup of
tea!
Continue reading...
By Mitch on Wednesday 9 November 2011, 22:41 - Templates
Here is the first template I want to share with you. Software
Requirements Specifications, is the main document to fill with technical
requirements of your software. It contains entries compliant with IEC 62304,
IEC 62366 and ISO 14971.
Please, fell free to give me feedback on my e-mail contact@cm-dm.com
I share this template with the conditions of CC-BY-NC-ND license.
This work is licensed under a
Creative Commons
Attribution-NonCommercial-NoDerivs 3.0 France License.
Friday 4 November 2011
By Mitch on Friday 4 November 2011, 14:20 - Regulations
Medical devices shall have CE mark before being sold in the EU. The process to have CE mark can be summarized this way:
- Determining the class of the device,
- Choosing the CE procedure to apply,
- Declaring CE conformity of the device.
Software follows exactly the same process as other devices. Here are the steps to follow to CE mark software.
Continue reading...
By Mitch on Friday 4 November 2011, 13:21 - Standards
A lot of standards and regulations exist about medical devices: how to design, to produce, to sell, to monitor their use … Everything about each step in the life of devices, from the initial idea 10 years before selling anything, to the archiving of records 10 years after the last item has been sold.
A lot of specific standards or guidances on how applying medical devices standards exist about software. That’s the consequence of software being very specific (I should say peculiar), compared to other components in medical devices. Conception is the most critical part in the lifecycle of software. Software is never 100% finished, user always want enhancements and modifications.
From my own experience in the field, I gathered 5 basic recommendations you should follow.
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Tuesday 1 November 2011
By Mitch on Tuesday 1 November 2011, 23:00 - Standards
Here is a short description of ISO and IEC standards related to software and medical devices.
The starting point is legal. Government agencies give the authorizations to manufacturers to sell their devices. These agencies rely on standards to ensure that the device was designed and manufactured in a good and safe way. Given these regulations, private companies have to adhere to these standards. Full stop.
Let's see what these standards are.
General standards
Two ISO standards are of high importance for software medical devices: ISO 13485 and ISO 14971. They can be seen as the topmost standards for medical devices. They are very generic and apply to every medical device, from the simplest plaster to the most complex surgeon robot. As they are so generic, they don’t give a clue about software. Other standards do.
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Monday 3 October 2011
By Mitch on Monday 3 October 2011, 13:01 - Read me first
The content of this website is the property of Cyrille Michaud. You can use
the articles with respect to Creative Commons Attribution-NoDerivs 3.0
(CC-BY-NC-ND) License. See Creative
commons license deeds and Creative commons license legal code.
Waiver:
Precision about templates: You can freely download and fill the templates
posted on this site, to produce technical documentation. The documents produced
by filling the templates are outside the scope of the license. However, the
modification of templates to produce new templates is in the scope of the
license and is not allowed by this license.
Why do I use CC-BY-ND licence? Please, have a look at Licenses for Works of
Opinion and Judgment on GNU website.
This work is licensed under a
Creative Commons
Attribution-NonCommercial-NoDerivs 3.0 France License.