Software in Medical Devices, a blog by MD101 Consulting

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Tag - IEC 82304

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Tuesday 1 November 2016

IEC 82304-1:2016 Health software - Part 1: General requirements for product safety

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

IEC 82304-1 - Consequences on agile software development processes

Continuing our series about IEC 82304-1, let's see the consequences of this standard on agile software development processes.

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Friday 11 March 2016

IEC 82304-1 - Overview of requirements

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.

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Friday 5 February 2016

New FDA draft guidance on interoperable medical devices

The draft guidance about Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices was published late January 2016.

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Friday 15 January 2016

IEC 82304-1 - latest news about the standard on Health Software

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.

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