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Medical device quality, regulatory and safety professional

Artificial Intelligence as a Medical Device AIaMD software manufacturers are you ready for the Medicines and Healthcare products Regulatory Agency AIRLOCK! https://lnkd.in/enZvfKJ6 We’ve acknowledged for sometime that the current conformity assessment processes associated with software as medical devices does not necessarily best-fit into the ‘physical’ engineered medical device framework therefore the MHRA and other collaborators such as Team AB (U.K. approved conformity assessment bodies) have established a pilot for a digital ‘airlock’ so that software developers can submit their products into a non-clinical environment and be soak tested to see for example of the algorithm ‘drifts’ as well as look for other hazards and hazardous situations. There is a webinar on the 6th June hosted by the MHRA on this topic here https://lnkd.in/esU-hhGp Bravo MHRA for dusting off that medical device safety leadership!!!!

AI Airlock: the regulatory sandbox for AIaMD

AI Airlock: the regulatory sandbox for AIaMD

gov.uk

James Pink

Medical device quality, regulatory and safety professional

5mo
James Pink

Medical device quality, regulatory and safety professional

5mo
James Pink

Medical device quality, regulatory and safety professional

5mo
James Pink

Medical device quality, regulatory and safety professional

5mo
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Erik Vollebregt

Partner at Axon Lawyers: life sciences | medical devices | IVDs | medicines | biotech | AI | REACH | Batteries | EU law | Dutch law | M&A | commercial contracts | due diligence | healthcare | (regulatory) litigation

5mo

"Open the pod bay doors HAL" "I'm afraid I can't do that Dave" That's my airlock association (and the Alien queen being vented in Aliens of course) Whatever it's called, let's hope it's better thought through than the EU sandbox - which has a completely unclear relationship to other regulated forms of testing of AI, such as clinical investigation.

Better than Sandpit (in my opinion) but now I read Airlock and I conjure up mental images of manufacturers stuck in an isolation chamber, clawing at the windows and doors, hoping not to be jettisoned out into the cold, harsh reality of space. Maybe I need to keep my imagination in an airlock.

Antje Marquardsen

Senior Director, Global Regulatory Affairs at 3Shape

5mo
Kate Wall

Senior Manager, Regulatory Affairs, EMEA, Abbott Medical

5mo

Roland Back webinar on the 6th June

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