QUALITY MANAGEMENT SYSTEM
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
ClearVue - Declaration of Conformity
UNITED STATES - FDA 510(k) cleared/PMA approved devices
ClearVue – 510 (k) clearance letter.
GLOBAL REGULATORY REPRESENTATIVES
EUROPE - Authorized Representative
Emergo Europe, The Hague, NETHERLANDS
Telephone: +31.70.345.8570
http://www.EmergoGroup.com
MATERIAL SAFETY DATA SHEETS
ClearVue
Orbital Therapy is fully compliant with IEC 60601-1 and ISO 10993.
All procedures were conducted in conformance with good manufacturing practices and certified to ISO 13485: 2003.
HRD-6 Fiber Optic Dosimeter
Fiber Optic Dosimeter has successfully passed Immunity (Immunity Test Report) and Emission tests (Emission Test Report) and is fully compliant with:
EN61000-4-2:1995, A1:1998, A2:2001
EN 61000-4-3:2006
EN 61000-4-4:1995, A1:2001, A2:2002; 2004
EN 55024:1998, A1:2001, A2:2003
CFR47 Part 15: 8/14/2006 (FCC)
EN55022: 2006 (EU Emissions)
CISPR22: 3rd edition 2006 (Worldwide Emissions)
AS/NZS: CISPR 22: 3rd edition 2006 (Australia & New Zealand Emissions)
ICES-003: issue 4, 2/2004 (Canadian Emissions)
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