CERTIFICATIONS

ISO 13485 Quality System Certification

ISO 13485:2016 Certificate (107K)

MDSAP Certificate (127K)

US FDA Good Manufacturing Practice (GMP)
We are fully compliant with 21 CFR 820, US FDA Quality Systems Regulations.

Europe - EC Certificate

MDR Certificate (409K)


EUROPE DECLARATIONS OF CONFORMITY

MDR

Class I Devices (803K)

Class IIa Devices (445K)

 

Please direct any requests or inquiries regarding product compliance to the following: regulatory@americanortho.com