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Archives:
Dokumente
Clinical Evaluation (medical devices) – Structure and contents
June 24, 2024
Notification of Change (MDR)
June 24, 2024
Questionnaire for a quotation – Medical devices – Appendix II: Questionnaire Medical Devices class Ir (if applicable)
June 24, 2024
Questionnaire for a Quotation (Opinion under Regulation (EU) 2017/745 Article 117)
June 24, 2024
General Safety and Performance Requirements according to Annex I of Regulation (EU) 2017/745
June 24, 2024
Rules for certification procedures according to Regulation (EU) 2017/745
June 24, 2024
Questionnaire for a quotation – Medical devices
June 24, 2024
Price List – Certification according to Regulation (EU) 2017/745 (MDR) & Recognition in Third Countries
June 24, 2024
Technical Documentation (Medical Devices) – Reusable surgical instruments (class Ir)
June 24, 2024
Guideline for the submission of electronic instructions for use
June 24, 2024
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