|
General information |
|
|
|
Company brochure (german) |
 |
[348KB] |
|
Company brochure (english) |
|
[342KB] |
|
Firmenprospekt (russian) |
|
[232KB] |
|
Declaration of Conformity MDD |
 |
[36KB] |
|
Declaration of Conformity IVD |
|
[36KB] |
|
|
|
|
Brochure"Basic Information about the
European Directive 93/42/EEC on
Medical Devices" (deutsch) |
|
[224KB] |
Brochure"Basic Information
about the European Directive 93/42/EEC on
Medical Devices" (english) |
|
[212KB] |
|
|
|
|
Brochure "Basic Information about the
European Directive 98/79/EC on
In vitro Diagnostic" (deutsch) |
|
[196KB] |
Brochure "Basic Information
about the European Directive 98/79/EC on
In vitro Diagnostic"
(english) |
|
[181KB] |
|
|
|
|
|
Quotation for certification |
|
|
|
Questionaire for the Preparation of a
Quotation
(deutsch) |
|
[872KB] |
|
Questionaire for the Preparation
of a Quotation
(english) |
|
[778KB] |
|
|
|
|
|
List of products to be exported to Taiwan (deutsch) |
|
[31KB] |
|
List of products to be exported
to Taiwan (english) |
|
[30KB] |
|
|
|
|
|
Taiwan Registration - Application
Form (english) |
|
(255KB] |
|
Taiwan Registration - Standard
QSD mode (english) |
|
(18KB] |
Taiwan Registration - Simplified
mode of European Union
technical cooperation program (english) |
|
(18KB] |
|
[Note]
Further Information
Taiwan-Registration |
|
|
|
|
|
|
|
References/Lists of valid certificates |
|
|
|
List of certificates issued according to
EN ISO 13485 (german, alphabetical order) |
|
[324KB] |
List of certificates issued according to
EN ISO 9001 and EN ISO 15378
(german,
alphabetical order) |
|
[164KB] |
|
List or certificates issued according to
QEP Program (quality and development in surgeries, german,
alphabetical order) |
|
[117KB] |
|
|
|
|
|
Use of Certification, Certificate and
Certification Mark (german) |
|
[124KB] |
|
Use of Certification, Certificate
and Certification Mark
(english) |
|
[119KB] |
|
|
|
|
|
Because of the requirements regarding secrecy according to the
EC-Directives, mdc does not publish any lists of certificates
according to the EC-Directives 93/42/EEC and 98/79/EC |
|
|
|
|
|
|
|
Checklists, further documents |
|
|
|
Checklist, "Essential requirements
according to the MDD 93/42/EEC, Annex I" (german) |
|
[411KB] |
|
Checklist, "Essential
requirements according to the MDD 93/42/EEC, Annex I"
(english) |
|
[390KB] |
|
Checklist, "Essential requirements
according to the IVDD 98/79/EC, Annex I" (german) |
|
[392KB] |
|
Checklist, "Essential
requirements according to the IVDD 98/79/EC, Annex I" (english) |
|
[389KB] |
|
Notification of changes (german) |
|
[28KB] |
|
Notification of changes (english) |
|
[27KB] |
|
|
|
|
|
|
|
|
