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Accreditation EN ISO 13485:2021
Application for inspection of manufactured products according to annex IV.6 of Directive 98/79/EC
Clinical Evaluation (medical devices) – Structure and contents
Common Issues in the Submission of Technical Documentation for In Vitro Diagnostic Devices (IVDs)
Data protection information for customers and interested parties
Designation_IVDR
Designation_MDR
General Rules for Certification Procedures
General Safety and Performance Requirements according to Annex I of Regulation (EU) 2017/745
General Safety and Performance Requirements according to Annex I of Regulation (EU) 2017/746
General Terms And Conditions – Seminars
General Terms of Business
Guideline for the submission of electronic instructions for use
Guidelines for digital submissions
Information electronic signature
List of critical suppliers / OEM-Manufacturers (DIR, standards)
List of forged certificates / Liste Zertifikatsfälschungen
List of In Vitro Diagnostic Medical Devices (IVDR)
List of Medical Devices (MDR)
List of products – In-vitro Diagnostic Devices (CE 0483)
List of products – medical devices (CE 0483)
Notification of Change (MDR)
Notification of Change (Regulation (EU) 2017/746)
Notification of Changes (MDD/IVDD)
Notification of Changes (QM Standards)
Power of Attorney/Vollmacht
Price List – Certification according to Regulation (EU) 2017/745 (MDR) & Recognition in Third Countries
Price List – Certification according to EC Directive 98/79/EC (IVDD)
Price List (Certification according to IVDR)
Price List (Certification According to QM Standards)
Privacy information for job application
Privacy information mss 2.0
Privacy policy for IT-supported audio-/video conferences
Process Description “Technical Cooperation Programme” (TCP) – Taiwan
Process Description Certification of Quality Systems
Process Description Cooperation Procedure for Approvals in Ukraine
Questionnaire for a quotation – In-vitro Diagnostic Devices
Questionnaire for a quotation – Medical devices
Questionnaire for a quotation – Medical devices – Appendix II: Questionnaire Medical Devices class Ir (if applicable)
Questionnaire for a Quotation (Opinion under Regulation (EU) 2017/745 Article 117)
Questionnaire for a Quotation (QM Standards)
Questionnaire MDSAP (Basic Data) – DQS
Questionnaire MDSAP (Basic Data) – Guidance: How to comlete
Rules for certification procedures according to Regulation (EU) 2017/745
Rules for certification procedures according to Regulation (EU) 2017/746
Specific Regulations for Certification Processes according to MDD 93/42/EEC and IVDD 98/79/EC
Structure of Technical Documentation (Medical Devices)
Technical Documentation (In-vitro Diagnostic Devices)
Technical Documentation (In-vitro Diagnostic Devices) – File Structure (ZIP)
Technical Documentation (Medical Devices) – File Structure (ZIP)
Technical Documentation (Medical Devices) – Reusable surgical instruments (class Ir)
Use of Certification, Certificate and Certification Mark
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