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1. Services  
It is our mission to act as a specialist in the sector of medical devices, healthcare and related areas.  Our range of services in the field of assessment and certification has always been…  
2. Appeals and Complaints  
Please use the form below to submit an appeal or a complaint. We will do our best to answer your request as soon as possible. For more information on handling complaints and appeals, please refer…  
3. Independence  
As a Notified Body and Certification Body, our strength and objective is to perform audits, activities, assessments, and evaluations. Strict independence, objectivity, neutrality, and…  
4. Forms - templates - further documents  
Medical devices Contents of Technical Documentation for MDD 93/42/EEC and IVDD 98/79/EC (PDF) Structure of Technical Documentation according to regulation 2017/745 (MDR) and MDD 93/42/EWG (PDF)…  
5. Liste_entzogener_ausgesetzter_Zertifikate_2019-03-13.pdf  
Liste entzogener und ausgesetzter Zertifikate List of withdrawn and suspended certificates Zertifikat / Certificate D1352300001 D1401900002 D1396200005 D1066300010 D1066300009 D1130600020 D1320800006…  
6. Terms & conditions  
General Terms of Business of mdc medical device certification GmbH (PDF)   Process descriptions Certification of OEM Devices (PDF) Certification of Quality Systems (PDF) Technical…  
7. 120302_e_016_02_2019_price_list_QM.pdf  
Price List (Certification according to QM standards) 016/02.2019 120302_e 1. Certification Costs Information Basic information about the requirements of the procedure and costs of a certification…  
8. 3219_e_002_02_2019_price_List_EC_directives_MDSAP.pdf  
Price List - Certification according to EC Directives and MDSAP 002/02.2019 ID: 3219 1. Certification Costs Information Basic information about the requirements of the procedure and costs of a…  
9. 120403_e_Application_IVDD.pdf  
Application for Certification according to IVDD 98/79/EC 011/01.2019 120403_e.docx After being checked and signed by mdc this application is a valid Certification Contract between mdc medical…  
10. 120402_e_Application_MDD.pdf  
Application for Certification according to MDD 93/42/EEC 011/01.2019 120402_e.docx After being checked and signed by mdc this application is a valid Certification Contract between mdc medical…  
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