• ISO 9001:2000 Certificate
  International Standard for Quality Management Systems
   
• ISO 13485:2003 CMDCAS Certificate
  International and Canadian Standard specifies the quality system requirements for the design/development, production and, when relevant, installation and servicing of medical devices
   
• CE Certificate
  Council Directive 93/42/EEC, Annex II, Section 3.2.
  Medical Device Directive

United States: Food and Drug Administration (FDA)

The following product modules are regulated and subject to pre-market notification requirements by the FDA:

• SEQUENCER
• MLC Fit
• ViewStation
• QwikSIM

FDA Pre-Market Notification Information

European Community: CE Marking (MDD)

IMPAC maintains a Quality System that complies with all essential requirements of the Medical Device Directive (93/42/EEC) and all other standards applicable there under. A Technical File is maintained for review via the Authorized Representative and IMPAC directly.

Authorized Representative:
CEpartner4U, 3951DB; 13.NL.
Tel: +31 (0) 6-516.536.26, or
CEpartner4U, Esdoornlaan 13,
3951DB Maarn. The Netherlands
Tel: +31 (0) 6-516.536.26

EC Certificate: CE 77310
BSI Certificate: FM 78409, FM 77311, FM 77312
Notified Body ID number: 0086

Declaration of Conformity

IMPAC's Declaration of Conformity

Canada: Health Canada

Medical Device License numbers:
ViewStation 6504
QwikSIM 33413
SEQUENCER 13100
MLC Fit 6510

Australia: Therapeutic Goods Administration (TGA)

TGA identification numbers:
ViewStation 160653
QwikSIM 160654
SEQUENCER 160655
MLC Fit 160656

AQAS Australian Business Number (ABN) number: U3885019

Authorized Representative:
Andromeda Quality Assurance Systems
22 Railway Street
Rooty Hill. New South Wales 2766
Australia

IMPAC Regulatory Affairs Contact

Thomas H. Faris
Management Representative
Vice President of Regulatory Affairs & Quality Assurance,
Chief Privacy Officer
IMPAC Medical Systems, Inc.
100 Mathilda Place, 5th Floor
Sunnyvale, CA 94086
408-830-8000
Tfaris@impac.com