MDD-02 Quotation Request Form MDD - DOC by olliegoblue35

VIEWS: 11 PAGES: 2

									DET NORSKE VERITAS CERTIFICATION AS


                                         CE-MARKING

           QUOTATION REQUEST FORM FOR MEDICAL DEVICES

Manufacturer’s name:                                                                       Date:

Address:


Contact person:                                         Contact person`s telephone / fax:


Number of employees:

Main site:…………………………………….               Additional site:……………………………..
Additional Sites:

Please list any Subcontractors used for critical processes (e.g. sterilization or main part of production):
………………………………………………………………………………………………………….

Initial Certification              Recertification   




Quality System information /request for services:
We have the following Quality system:
ISO 9001  Exp. Date______              Certified by:    DNV      Other 
ISO 13485  ISO 13488  Exp. Date______
                                        Name of other: ______________Pls. enclose copy.

We would like to apply for the following:              ISO 9001:2000            ISO 13485:2003
                                                       ISO 13485:1996            ISO 13488:1996


Conformity assessment procedure
The manufacturer chooses the procedure based on class of medical device:
 Class      Procedure                                                                               Please indicate
                                                                                                     preference:
  Is      Annex V + Annex VII         (Notified Body + Self assessment)
  Im      Annex VI + Annex VII        (Notified Body + Self assessment)
  IIa     Annex V+ Annex VII          (Notified Body + Self assessment)
  IIa     Annex II ÷ section 4
  IIb     Annex II ÷ section 4
  III     Annex II
Class I device with a “m” = Measuring function or placed on the market in a “s” = Sterile Condition

Note: Please list medical devices to be CE-marked on page 2

C5-ce-a2-3-MDD-02                                                   Date:      Revision:           Page:
                                                                  2003-11-26      04               1 of 2
DET NORSKE VERITAS CERTIFICATION AS


Please tick the box if the Medical Device incorporates:
Radio and Telecommunication equipment1  Yes                        No

List of Medical devices to be CE marked
Specify and please copy this page if more space is needed:

Medical Device Generic Group                      Model/variants to be CE                       Medical       Sterile
        incl. Software                                   marked                               Device Class
Short description of device and indented                                                      according to
                   use                                                                            rule




Medical Devices already CE marked by another Notified Body:

Date:           Signature:


For local DNV unit:
Lead auditor
Branch Expert (s)
Information provided by        Date:                            Sign.:



1
 Radio equipment: Product communicating by radio waves
Telecommunication terminal equipment: Product connected directly or indirectly to public telecommunications
network
C5-ce-a2-3-MDD-02                                                        Date:    Revision:          Page:
                                                                     2003-11-26      04              2 of 2

								
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