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Friday, 6 December 2019
By Mitch on Friday, 6 December 2019, 14:10 - Regulations
So we have a corrigendum (almost 100% sure. A vote by the EU Parliament is still in the pipe December the 16th, though). To corrigendumize: that's a neologism I propose to name bug fixing activities in legal matters. I corrigendumize, you corrigendumize, they corrigendumize! Any resemblance to "randomize" is purely coincidental!
Tuesday, 1 November 2016
By Mitch on Tuesday, 1 November 2016, 21:09 - Standards
IEC 82304-1:2016, the missing link on standalone medical device software validation has been published!
See the official version on IEC webstore, and comments made on the FDIS (the final version shouldn't have changed).
Now we wait for the FDA to recognize it and the EU to harmonize it!
Friday, 8 April 2016
By Mitch on Friday, 8 April 2016, 14:25 - Standards
Continuing our series about IEC 82304-1, let's see the consequences of this standard on agile software development processes.
Friday, 11 March 2016
By Mitch on Friday, 11 March 2016, 14:53 - Standards
We had in a previous article an overview of IEC 82304-1 Health software -- Part 1: General requirements for product safety, its scope and its relationships with other standards like IEC 62304.
This article presents more in details (but not too much, we're not going to rephrase the standard) the requirements of IEC 82304-1.
Friday, 5 February 2016
By Mitch on Friday, 5 February 2016, 13:45 - Regulations
The draft guidance about Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices was published late January 2016.
Friday, 15 January 2016
By Mitch on Friday, 15 January 2016, 14:30 - Standards
IEC 82304-1 Health software -- Part 1: General requirements for product safety standard is still under development. Its status is visible on the page of ISO website, dedicated to IEC 82304-1. There is even a preview of the first three pages of this draft standard.
