Axim Biotechnologies Inc (AXIM)

[TexasMarvL]

The FDA to adopt #ISO13485 standards.
The following article is from October 2023 and explains the similarities and differences between FDA-820 and ISO-13485. The FDA is in the process of upgrading their standards for medical devices to meet the International Standards Organization 2016 version of ISO-13485.


https://www.greenlight.guru/blog/qmsr-quality-management-system-regulation#:~:text=In%20its%20proposed%20rule%2C%20FDA,regulatory%20expectations%20for%20QMS%20for

It is great to know that Auer Precision is already certified to ISO-13485 standards.