Latest news in areas of software development and medical device regulation:

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• Debate on the use of AI in medical apps hots up!

• Canada delays launch of new regulatory system for SaMD (ext link in new window)

• FDA issues draft guidance on the content of pre-market submissions in relation to cybersecurity

• New UK medical device regulations delayed until 2025

• Recent dialogue between IPEM and MHRA 

• New IPEM guidance on in-house manufacturing and use (IHMU)  - July 2022  (opens in a new window)

 

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This page last updated: 21 June 2023