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Medical Device

Medical Devices Documentation Download

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Welcome to the Download Area Medical Devices

In our download area we have compiled a large number of helpful downloads for you. Here you will find information on testing and certification of medical devices, customer information, fact sheets, the customer questionnaire on certification and KBV applications for download as PDF files.
 

Downloads

Customer information

Complaints and appeals (German/English)
PDF
148 . 42 KB
Download
Declaration of interest (English)
PDF
589 . 82 KB
Download

Customer questionnaire for certification

Questionnaire for certification of quality management systems according to EN ISO 13485 (English)
PDF
399 . 80 KB
Download
Questionnaire for certification of Medical Devices according to MDR (English)
PDF
1 . 85 MB
Download

Factsheets of our services

Factsheet ISO 13485
PDF
2 . 15 MB
Download
Factsheet Medical Device Regulation (MDR)
PDF
507 . 63 KB
Download

Interactive Checklists

TÜV NORD MDR Readiness Checklist
PDF
39 . 93 KB
Download

Information about certification and testing of medical devices

Download section

Service descriptions and conditions of certification

Contact

Are you interested in learning more about a specific topic? Feel free to contact us!

Project Management Medical

medical@tuev-nord.de
Contact us

Discover your next service

Certification

ISO 13485

ISO 13485 certification ensures quality and compliance for medical devices.
Learn more about ISO 13485
Certification

MDR

Medical Devices Regulation - The new Medical Devices Regulation
Learn more about MDR certification
Certification

KRINKO/BfArM

Certification Reprocessing of medical devices up to and including critical C
Learn more about KRINKO/BfArM