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What Regulators Want To See From AI And Software-Based Devices

 
• By Eliza Slawther

Experts in software and AI medtech regulation from the UK’s MHRA have outlined the questions that device developers should seek to answer when preparing for the regulatory process.

Assessment
• Source: Shutterstock

Defining the intended purpose of a medical device should be the starting point for manufacturers entering the regulatory process, yet software-based devices often have a poorly-defined intended purpose, Paul Campbell, head of software and artificial intelligence at the UK regulator, the MHRA, told a conference on 6 July.

Campbell, who has just this month been appointed to lead on software and AI at the Medicines and Healthcare products...

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More from Geography

A Year After Exiting The Ventilator Market, Medtronic Recalls Thousands Of Newport Devices

 
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