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Regulatory Information

ISO, EN, CE Marking & More 

  • ISO 9001:2008 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 software product modules are regulated and subject to pre-market notification requirements by the FDA:

  • SEQUENCER
  • MLC Fit
  • ViewStation

FDA Pre-Market Notification Information 

European Community: CE Marking (MDD) 

Elekta Software 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 Elekta Software 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

Elekta Software's Declaration of Conformity

Canada: Health Canada

Medical Device License numbers:

  • ViewStation 6504
  • SEQUENCER 13100
  • MLC Fit 6510

Australia: Therapeutic Goods Administration (TGA) 

TGA identification numbers:

  • ViewStation 160653
  • 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

Contact Us with Questions or Concerns 

Elekta Region North America

For more information about Elekta Region North America HIPAA efforts, HIPAA, , Privacy, Security, or any other regulatory matter, please contact:
    
Thomas Valentine
Chief Privacy Officer (CPO)
Vice President of Regulatory Affairs and Quality Assurance (RA/QA)
Elekta Inc.
4775 Peachtree Industrial Blvd.
Building 300, Suite 300
Norcross, GA 30092
+1 800 353 7355
Thomas.Valentine@elekta.com

For any urgent concerns when Mr. Valentine is not available, please call +1 800 353 7355 and ask for any member of the RA/QA department. 

Elekta Software

For more information about Elekta Software’s HIPAA efforts, HIPAA, Privacy, Security, or any other regulatory matter, please contact:

Chris Ivicevich
Chief Privacy Officer (CPO)
Director of Regulatory Affairs and Quality Assurance (RA/QA)
Elekta: Impac Software
100 Mathilda Place, Fifth Floor
Sunnyvale, CA 94086
+1 888 464 6722
Chris.Ivicevich@elekta.com 

For any urgent concerns when Mr. Ivicevich is not available, please call +1 408 830 8000 and ask for any member of the RA/QA department.