Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices

Titel:
Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices
Herkunft/Verlag:

GHTF

Dokumentenart:
Guideline
Inhalt:
This document is intended to provide guidance on the content of the STED for IVD medical devices to be assembled and submitted, where applicable, to a RA or CAB for premarket review, and for use post-market to assess continuing conformity to the Essential Principles.

Zurück

GMP Seminare nach Thema

Cookies helfen uns bei der Bereitstellung unserer Dienste. Durch die Nutzung unserer Dienste erklären Sie sich damit einverstanden, dass wir Cookies setzen. Weitere Informationen

OK