FDA Clearance

 Certification of Company

 

Erchonia is committed to “Quality Not Compromise”. To ensure ourselves and our clients, that we have achieved and maintain that goal, we have a quality process that is externally audited annually by a 3rd party. Each year Erchonia Medical is audited to determine if we meet and exceed the Quality standards of Canada, Eur-Asia and the United States. Not only do we undergo scrutiny for general Quality (ISO-9001), but we are also audited against the stricter Quality standard for Medical devices (ISO-13485). In addition to ISO (International Organization for Standardization), we conform to and are regulated by FDA and CDRH (Center for Devices and Radiological Health) standards. Our certificates along with FDA registration can be viewed through the documents and links below. 

 

 

Certificates

 

SGS Certificate

ISO 13485 : 2003

 

 

 

 

 

 

 

 

SGS Certificate

ISO 13485 : 2003
EN ISO 13485 : 2012

 

 

 

 

 

 

 

 

Links

 

Establishment Registration: 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/Registration.cfm?ID=19821  

type ERCHONIA in the the Establishment field

 

Device Listings: 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/listing.cfm

type ERCHONIA in the the Establishment field