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Directive 93/42/EEC – MDD – Medical Devices Directive with 2007/47/EC – Consolidated Version
GHTF – Global Harmonization Task Force – Guidelines
MDD 93/42/EEC of 14 June 1993 concerning medical devices – Original directive
TITLE 21CFR 820 QUALITY SYSTEM REGULATION
Directive 90/385/EEC – AIMDD – Active Implantable Medical Devices Directive – Consolidated Version
DIRECTIVE 98/79/EC – IVD – In vitro diagnostic medical devices – Consolidated Version
Canada Medical Devices Regulation
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FDA REGULATION
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Webinar – Traditional 510(k) – FDA Registration – US Medical Device Regulatory + 510(k) Ready Template
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WEBINAR FDA REGISTRATION: MEDICAL DEVICE, IVD, COMBINATION DEVICE
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