Welcome to the CP Medical Regulatory Compliance page. We hope this links and information are useful to our customers.

QUALITY MANAGEMENT SYSTEM
ISO 13485 quality system certification
MDSAP certification
CP Medical Devices maintains an MDSAP certification and is audited every year by:
DQS Medizinprodukte GmbH 
August-Schanz-Str. 21, 60433 Frankfurt am Main, Germany
T +49 69 95427-8112 ∙

US FDA (21 CR Part 820) compliance
We are fully compliant with the US FDA Quality System Regulation. View our Establishment Registration on the FDA website. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?rid=188311

PRODUCT CERTIFICATIONS AND APPROVALS
CANADA- Medical Device Licenses
• Bone Wax License
• Polypropylene Polypro License
• Nylon Monimid License
• Polyester Polybond License
• Silk License
• Visorb Quick License
• Visorb PGA License
• Mono-Dox PDO License
• Plain & Chromic Gut License

UNITED STATES – FDA 510(k) cleared (Links to US FDA database device listing)
CP Medical Establishment Registration & Device Listing

GLOBAL REGULATORY REPRESENTATIVES
EUROPE – Authorized Representative
MDSS GmbH
Schiffgraben 41, 30175 Hannover, Germany
Tel.: +49 511 6262 8630
ww.mdssar.com