Canada
The article provides a brief overview of the approach to be applied when using standards for demonstrating compliance with the relevant regulatory requirements.
Canada
The new article explains further the way the approach described in the document should be implemented.
SAHPRA
The new article highlights the aspects related to the costs associated with establishment licenses, and supporting documentation interested parties should submit, and also explains cooperation between different regulating authorities and bodies.
North America
The medical device regulating authority in the United States, the FDA, issued special warning on cybersecurity threats related to cardiac implantable devices (ICDs). According to the document placed on the official website, the FDA aims to alert both companies and...
North America
The FDA is in the process of implementing the Unique Device Identification (UDI) System in a series of phases. Currently, all Class III and implantable, life-supporting and life-sustaining medical devices require UDIs. The next phase of the system will be implemented...
