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Category: Medical Device

Medical Devices – Regulatory Updates – August Volume 2

EUROPE 1.Guidance for industry on MHRA’s expectations for return to UK on-site inspections In line with a reduction in restrictions, the inspectorate plans to resume an on-site UK risk-based...

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Clinical Outcome Assessments (COAs) in Medical Device Decision Making

A clinical outcome assessment (COA) describes or reflects how a person feels, functions, or survives and can be reported by a health care provider or a non-clinical observer (such as a parent), through...

clinical outcomes assessment in devices, Clinician reported outcomes (ClinROs), Observer reported outcomes (ObsROs), Patient-reported outcomes (PROs), Performance outcomes (PerfOs)

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