Software in Medical Devices, by MD101 Consulting

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Friday 26 March 2021

When Web meets SOUP

The definition of SOUP, and the requirements related to their lifecycle in IEC 62304 processes, are totally independent of any technology. Making no technological assumption, that's the way the standard is thought, so that it can be applied to any health software.
Cloud-based applications and web technologies make an intensive use of SOUPs. Let's see how IEC 62304 requirements can be applied to these technologies.

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Friday 5 February 2021

FDA about to exempt fifteen software devices from 510k clearance

A Notice was published in the Federal Register the 15th January 2021, about the exemption of a long list of medical devices from premarket notification. This list, found in table 6 of the Notice, contains 83 class II devices.
Yet, we have to wait for 120 days, to see this Notice published with the list in its final version.

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Wednesday 9 October 2019

What happened to my Drug Prescription Assistance Software?

We know that Drug Prescription Assistance Software are software as a medical device, thanks to the European Court of Justice. But how to CE mark that kind of software?

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Sunday 26 May 2019

MDR: one year left and too late for class I software

Today is the 26th of May 2019. Rings a bell? In one year exactly, your class I MD software will be living in borrowed time on the EU market.
Why?
Because of rule 11 of 2017/745/UE Medical Device Regulation (MDR).

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Friday 19 January 2018

FDA Guidance on Medical Device Accessories updated

Here is a quick follow-up of the new version of the FDA Guidance titled Medical Device Accessories – Describing Accessories and Classification Pathways, published in December 2017. This comes a bit in parallel to the Section 3060 guidance described in the previous post on the 21st Century Cures Act.

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