Logo
Login Sign Up
Current Revision

AAMI ANSI/AAMI/ISO 14155:2020

Clinical investigation of medical devices for human subjects—Good clinical practice
Best Price Guarantee
Instant

$330.00

2-5 Days

$330.00

SAVE 10%

$594.00


Sub Total (1 Item(s))

$ 0.00

Estimated Shipping

$ 0.00

Total (Pre-Tax)

$ 0.00


View in Library
or
Assoc. for the Advancement of Medical Instrumentation Logo

AAMI ANSI/AAMI/ISO 14155:2020

Clinical investigation of medical devices for human subjects—Good clinical practice

PUBLISH DATE 2021
AAMI ANSI/AAMI/ISO 14155:2020
This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices. For post-market clinical investigations, the principles set forth in this document can be followed as far as relevant, considering the nature of the clinical investigation (see Annex I). This document specifies general requirements intended to: protect the rights, safety and well-being of human subjects; ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results; define the responsibilities of the sponsor and principal investigator, and; assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
SDO AAMI: Assoc. for the Advancement of Medical Instrumentation
Document Number 14155
Publication Date Jan. 5, 2021
Language en - English
Page Count 88
Revision Level
Supercedes
Committee
Loading...

Failed to load document history.

Publish Date Document Id Type View