To content | To menu | To search
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.
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After the draft guidance of the FDA about mobile apps, after the guide on regulation of health apps by a UK medical charity, this MEDEV is the third document released in a few months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.
Friday, 25 November 2011
By Mitch on Friday, 25 November 2011, 15:51 - Regulations
In How to classify and CE mark software, I tried to make a thorough explanation about how to obtain CE mark for software medical devices. Here is a short explanation about Canadian rules.
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.
page 2 of 2 - next entries »
