Blog Archive

0
AAMI

PDF Standards AAMI TIR102:2019

U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
standard by Association for the Advancement of Medical Instrumentation, 08/30/2019

View Article
0
AAMI

PDF Standards AAMI TIR41: 2011/(R)2020

Active implantable medical devices – Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators
standard by Association for the Advancement of Medical Instrumentation, 11/30/2011

View Article
0
AAMI

PDF Standards AAMI TIR12:2020

Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
standard by Association for the Advancement of Medical Instrumentation, 09/17/2020

View Article