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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!
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.
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:
Software follows exactly the same process as other devices. Here are the steps to follow to CE mark software.
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.
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, medical device manufacturers have to adhere to these standards. Full stop.
Let's see what these standards are.
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.
Contact: mitch@cm-dm.com
Website: www.cm-dm.com
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.
Sunday, 10 January 2010
By Mitch on Sunday, 10 January 2010, 18:35 - Read me first
This page was moved here: CC-BY-NC-ND License
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