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Nov 32 min read

SwissMedic Med Dev: Clinical Investigations of Medical Devices & Performance Studies of In Vitro Diagnostics (IVD)

The Swissmedic released (31 October, 2024) updated guidance on " Clinical Investigations with Medical Devices " and " Performance studies...

Nov 16, 20221 min read

Irelands HPRA MD Guide: Performance Studies Conducted in Ireland

Irelands Health Products Regulatory Authority (HPRA) released (16- November-2022) guide on "Performance Studies Conducted in Ireland", to...

Jun 18, 20221 min read

Ireland's HPRA -Guide to Performance Studies Conducted in Ireland

On 15-June-22, the HPRA released a guide on how to Performance Studies Conducted in Ireland. The term ‘performance study’ (PS) is defined...