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AI Act Starter Kit  
Your starter kit for compliance with the EU AI Act The essential quick start for IVD and medical device manufacturers  
Johner Institute North America  
Our mission is to help medical device manufacturers overcome regulatory challenges and bring safe products to market faster. Can we help you with that? Regulatory Intelligence Our…  
Johner Institute's Medical Device University  
Level up your medical device skills, grow your career and get your medical device to market faster! Get in touch (North America) Get in touch (Europe) Self-Assessments and Course Completion…  
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:…  
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…  
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…  
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…  
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…  
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…  
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…  
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