International Regulatory Compliance Information
Please note: Typical online retailers can not offer you a quality system that is verified by third parties, and none offer the compliances in total that we have successfully maintained, in most cases for over 30 years! Most of our competitors haven't even attempted to pass these worldwide standards for quality assurance.
QUALITY MANAGEMENT SYSTEM
ISO 13485:2016/EN ISO 13485:2016 | VIEW
US FDA Good Manufacturing Practice (GMP)
We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations.
PRODUCT CERTIFICATIONS AND APPROVALS
EUROPE - CE Marking certificates | VIEW
UNITED STATES - FDA 510(k) cleared/PMA approved devices | SEARCH FDA WEBSITE HERE
CERTIFICATE TO FOREIGN GOVERNMENTS | VIEW
GLOBAL REGULATORY REPRESENTATIVES
Shown below are our European representatives for regulatory affairs issues and incident reporting:
29 Harley Street
LONDON W1G 9QR
NOTIFIED BODY / REGISTRAR / CERTIFICATION BODY
Persona Medical Devices maintains ISO and CE certification and is audited every year by our registrar:
SGS North America Inc.
515 West Greens Road
Houston, TX 77067