Notified bodies and data protection officers ask different questions of the same device. Where the health data sits, and what to do about it.
Read MoreHow to write a clear intended purpose for software as a medical device, step by step.
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News and guidance on EU and UK regulations for medical devices, IVDs and general products. The newest posts are shown first.
All updates · EU MDR & IVDR · EUDAMED · UK & MHRA · Standards · Product safety / GPSR · Software & data
Notified bodies and data protection officers ask different questions of the same device. Where the health data sits, and what to do about it.
Read MoreHow to write a clear intended purpose for software as a medical device, step by step.
Read More