Global Medical Device Standards

Regulation of medical devices is growing rapidly each year. As a result, it is important for organizations to familiarize themselves with the Global Medical Device Standards. Below are the links to the five countries or regions with the most advanced medical device regulations. 
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 Standards, Regulations & Guidelines 

European Medical Device Regulations Directives (MEDDEV):

Canadian Medical Device Regulations (CMDR)

Australian Medical Device Regulations (ARGMD)

Japanese Medical Device Regulations & Guidelines

MAKE ISO 13485 CERTIFICATION SIMPLE AND FOOLPROOF!


Our All-in-One Certification Package is a proven, efficient system. It gives you all you need to prepare for registration – in one simple to use package.

Customer Review:

"I have just passed my ISO Audit with zero non-conformances for the second year in a row using your ISO products to write my entire QMS. Thank you for producing documents of this quality"

Bettye Patrick

Buy the Standard

13485 Store Logo ISO 13485