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Statistical requirements in medical diagnostic development across the UK, US, and EU markets: A review of regulation, guidelines and standards

Lookup NU author(s): Tim HicksORCiD, Joe Bulmer, Alison Bray, Dr Jordan OakleyORCiD, Dr Rachel BinksORCiD, Dr Kile GreenORCiD, Professor James WasonORCiD, Professor Kevin WilsonORCiD

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Author(s): Hicks T, Bulmer J, Bray A, Oakley JL, Binks RL, Green K, Jones WS, Wason JMS, Wilson KJ

Publication type: Article

Publication status: In Press

Journal: BMJ Innovations

Year: 2026

Acceptance date: 05/05/2026

ISSN (print): 2055-8074

ISSN (electronic): 2055-642X

Publisher: BMJ Group

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