QUALITY MANAGEMENT SYSTEM
ISO 13485 quality system certification for Europe (PDF format)
ISO 13485:2003 certificate
ISO 13485 quality system certification for Canada (PDF format)
ISO 13485:2003 certificate
US FDA Good Manufacturing Practice (GMP)
We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations.
PRODUCT CERTIFICATIONS AND APPROVALS
AUSTRALIA - Devices listed in ARTG (PDF format)
RadCalc
CANADA- Medical device licenses (PDF format)
RadCalc
EUROPE - CE Marking certificate (PDF format)
RadCalc
EUROPE - Declarations of Conformity (PDF format)
RadCalc
UNITED STATES - FDA 510(k) for External Beam Radiation Therapy Verification (PDF format)
RadCalc
UNITED STATES - FDA 510(k) for Brachytherapy Verification (PDF format)
RadCalc
GLOBAL REGULATORY REPRESENTATIVES
Shown below are our in-country representatives for regulatory affairs issues and incident reporting.
AUSTRALIA - Sponsor Representative
Emergo Australia, Sydney, AUSTRALIA
Telephone: +61.2.9006.1662
http://www.EmergoGroup.com
EUROPE - Authorized Representative
Emergo Europe, The Hague, NETHERLANDS
Telephone: +31.70.345.8570
http://www.EmergoGroup.com
UNITED STATES - US FDA Agent
Emergo Group, Inc., Austin, Texas USA
Telephone: +1.512.327.9997
http://www.EmergoGroup.com
NOTIFIED BODY / REGISTRAR / CERTIFICATION BODY
LifeLine Software, Inc. maintains its certification and is audited every year by:
SGS United Kingdom Ltd
Unit 202B
Worle Parkway
Weston Super Mare BS22 6WA
United Kingdom
Telephone: +44.1934.522.917
http://www.sgsgroup.us.com/en.aspx
