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What is ISO 13485:2016?

Here is a partial Sampling of a key Medical Device Quality System and the Standards from around the world:

ISO Standards and Guides for the Medical Device Quality System

US FDA Medical Device Regulations & Guidelines

 

European Medical Device Regulations Directives (MEDDEV):

 

Canadian Medical Device Regulations (CMDR)

Australian Medical Device Regulations (ARGMD)

Japanese Medical Device Regulations & Guidelines

 

ISO 9001 All in One Package

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