Certificate in EU MDR Documentation Requirements
-- ViewingNowThe Certificate in EU MDR Documentation Requirements course is a vital program for professionals in the medical device industry. The European Union Medical Device Regulation (EU MDR) introduced new documentation requirements, and this course provides essential knowledge to navigate these changes.
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โข Introduction to EU MDR Documentation Requirements: Overview of EU Medical Device Regulation (MDR) and its documentation requirements.
โข Technical File Preparation: Guidelines for creating and organizing a technical file for EU MDR compliance.
โข Clinical Evaluation Report (CER): Best practices for conducting and documenting clinical evaluations in accordance with EU MDR.
โข Post-Market Surveillance (PMS): Strategies for implementing and maintaining a robust PMS system to meet EU MDR requirements.
โข Vigilance and Incident Reporting: Procedures for monitoring and reporting adverse events and incidents as per EU MDR.
โข Quality Management System (QMS): Overview of establishing and maintaining a QMS in alignment with EU MDR.
โข Labeling and Instructions for Use (IFU): Guidelines for complying with EU MDR labeling and IFU requirements.
โข Summary of Safety and Clinical Performance (SSCP): Process for creating an SSCP to meet EU MDR documentation demands.
โข EU MDR Compliance Checklist: A comprehensive checklist for ensuring EU MDR documentation compliance.
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