long established technologies / technology/relevant previous experience / risk management / to medical devices / particular device / clinical investigation involving medical devices / combination products / information e.g. design solutions / voluntary / manufacturing process / diagnostic medical devices / /
MedicalCondition
disease / /
Organization
References World Medical Association / Regulatory Authority / Global Harmonization Task Force / /
GHTF/SG5/N3:2010 FINAL DOCUMENT Title: Clinical Investigations Authoring Group: Study Group 5 Endorsed by: The Global Harmonization Task Force