QUALITY MANAGEMENT SYSTEM
ISO 13485 Quality System Certification
VasSol received ISO 13485-2003 certification in 2007. ISO registration is achieved by implementing and demonstrating that the quality system functions in accordance with the standard.
US FDA Good Manufacturing Practice (GMP)
VasSol is fully compliant with 21 CFR Part 820, US FDA Quality System Regulations. These regulations relate to the methods used in the quality control of the device made by the company.
PRODUCT CERTIFICATIONS AND APPROVALS
UNITED STATES – 510(k) clearance
VasSol received US Food and Drug Administration 510(k) clearance in 2002. The 510(k) clearance is an order from the FDA that “clears” the device for commercial distribution in the U.S.
CANADA- Medical device license
VasSol received Medical Device License from Health Canada in 2007. The Canadian license recognizes that VasSol’s quality system conforms to all of the Health Canada standards.
EUROPE - CE Marking certificate
VasSol received the CE Marking certificate in 2007. The CE Mark certifies that a product has met the European Union (EU) health, safety, and environmental requirements which ensure consumer safety.
REGULATORY REPRESENTATIVE - EUROPE
Authorized Representative for regulatory affair issues and incident reporting
Emergo Europe, The Hague, NETHERLANDS
Telephone: +31.70.345.8570
http://www.EmergoGroup.com
NOTIFIED BODY / CERTIFICATION BODY - EUROPE
VasSol maintains ISO 13485:2003 certification and is audited every year by:
Intertek/SEMKO AB
Telephone: +46 87500000
http://www.intertek-sc.com