Certificate in EU Medical Device Certification Procedures
-- ViewingNowThe Certificate in EU Medical Device Certification Procedures is a comprehensive course designed for professionals seeking expertise in European medical device regulations. This course emphasizes the importance of understanding and navigating the complex EU certification procedures, a critical aspect of the medical device industry.
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โข EU Medical Device Regulation (MDR) and In-vitro Diagnostic Medical Device Regulation (IVDR): Overview of the new regulations and their impact on medical device certification procedures.
โข Classification of Medical Devices: Explanation of the rules for classification of medical devices according to their risk level and specific regulations for in-vitro diagnostic medical devices.
โข Clinical Evaluation and Technical Documentation: Requirements for clinical evaluation and technical documentation, including the preparation of a clinical evaluation report (CER).
โข Quality Management System: Overview of the quality management system (QMS) requirements for medical device manufacturers and the role of notified bodies in assessing compliance.
โข Vigilance and Post-Market Surveillance: Overview of the requirements for vigilance and post-market surveillance of medical devices, including reporting of serious incidents and field safety corrective actions (FSCAs).
โข Notified Bodies and Conformity Assessment: Explanation of the role of notified bodies in the conformity assessment process and the different types of conformity assessments for medical devices.
โข CE Marking and Declaration of Conformity: Requirements for CE marking and the preparation of a declaration of conformity, including the responsibilities of the manufacturer and the authorized representative.
โข Clinical Investigations and Performance Studies: Overview of the requirements for clinical investigations and performance studies, including the role of ethics committees and the preparation of a clinical investigation plan (CIP).
โข Transitional Provisions and Grandfathering: Explanation of the transitional provisions for medical devices already on the market and the concept of "grandfathering" for devices that have already been certified under the previous regulations.
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