QUALITY MANAGEMENT SYSTEM

ISO 13485 quality system certification for Europe
ISO 13485:2003 certificate (PDF format)

ISO 13485 quality system certification for Canada
ISO 13485:2003 certificate (PDF format)

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
RadCalc (PDF format)

CANADA- Medical device licenses
RadCalc (PDF format)

EUROPE - CE Marking certificate
RadCalc (PDF format)

EUROPE - Declarations of Conformity
RadCalc (PDF format)

UNITED STATES - FDA 510(k) for External Beam Radiation Therapy Verification
RadCalc (PDF format)

UNITED STATES - FDA 510(k) for Brachytherapy Verification
RadCalc (PDF format)

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

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