Posts tagged with "USA"

27. August 2018
A notice published by ISO indicates that the FDA may be considering to replace the Current Quality System requirements (as published under 21CFR820) by the ISO 13485 already in 2019. This would create a further step to the global harmonization....

01. August 2018
The annual update or the FDA user fees is now available on the FDA Website.

07. June 2018
With the modification FDA introduced some new standards that require some attention.

11. July 2017
Exemption from 510(k) for further 244 products