This is our second article in a series of Articles on: Branching out – Other Standards based upon ISO 9001.  This is #2 of 2 on ISO 13485 – Medical Standards. Who is requiring companies to be ISO 13485? ISO 13485 is recognized in most major markets (including the EU, US, Canada, Japan, and Taiwan). [...]

This is our first in a series of Articles on: Branching out – Other Standards based upon ISO 9001.  This is #1 of 2 on ISO 13485 – Medical Standards. What is ISO 13485 for Medical Devices? ISO 13485 is an ISO Standard, published in 2003. The ISO 13485 was designed for organizations that provide medical [...]