US AAMI adopts ISO14155
August 01 2011
The US Association for the Adavancement of Medical Instrumentation has adopted the revised international standard ISO 14155 on medical device clinical investigations.
A number of US experts made a significant contribution towards revising the standard and the AAMI decided to adopt the revised 14155 verbatim.
The new version of the standard is harmonised with ICH GCP as much as possible, but with key differences that apply only to medical devices. Previous to the revised standard device manufactures often used the ICH GCP guidelines for conducting device studies, despite it being more suited for medicinal product studies. Manufactures will now be able to apply ISO 14155 knowing that it has been adopted in the US.