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 ISO 13485:2003 certification and is audited every year by:

SGS U.S. Testing Company Inc.
515 West Greens Road, Suite 775
Houston, TX 77067
Telephone: +1.281.873.5800
Website link