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366 results:
Table-medical-device-file-incl-IVDR-V3.xlsx  
Document Medical device file according to ISO 13485:2016 Technical documentation according to MDR/IVDR Ref.: MDR (respective annex and section) Ref.: IVDR (respective annex and section) FDA: DMR,  
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EN_MEDDEV_2_7_1_CER_Checklist.docx  
Review of a Clinical Evaluation Report (CER) Content TOC \o "1-3" \h \z \u 1General information PAGEREF _Toc60857620 \h 12Reference documents PAGEREF _Toc60857621 \h 13Checklists for the review of  
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Checkliste-Importeur-V1_EN.docx  
Checklist for Importers This checklist is designed to help importers check that they are complying with the requirements of the MDR and IVDR. It assumes that the importer does not make any modificati  
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Privacy Policy  
Privacy Policy Last updated: 28/03/2022  Basic information on data processing and legal basis This data protection statement explains to you the type, scope and purpose for the process  
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Digital Transformation - Fit-for-future-Program  
Moving away from the document transfer station and regulatory uncertainty towards a regulatory affair that is "fit for future" Important note: The first run of the Fit for Future Program wit  
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Inhouse Seminars: Trainings tailored to your needs  
Inhouse Seminars: Trainings tailored to your needs If you want to book one of the seminars exclusively for your company, please get in touch with us. We are happy to adapt the seminars to your spec  
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User Interface Design What We Can Offer  
User Interface Design (higher-level menu) We create wireframes and prototypes, interaction and design proposals while considering heuristic design principles We identify suitable methods to sup  
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Latest Articles  
Here you can find our latest articles and the possibility to access our articles via the quick access function.  
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IT-Security  
What we offer Why you should choose a penetration test from Johner Institute: Database You benefit from tool-supported report generation and our vulnerability database.  
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Certificates  
Quality system and certificate Certificates To meet our own quality requirements, we have established a QM system and have been certified according to ISO 13485:2016 since 2018.  
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