Certificate in EU MDR Essentials
-- ViewingNowThe Certificate in EU MDR Essentials is a comprehensive course designed to provide learners with a solid understanding of the European Union Medical Device Regulation (EU MDR). This course highlights the importance of MDR in ensuring patient safety and product compliance in the EU medical device industry.
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GBP £ 149
GBP £ 215
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โข Introduction to EU MDR: Overview of EU Medical Device Regulation, its purpose, and benefits
โข Key Changes in EU MDR: Comparison of MDD (Medical Device Directive) vs. MDR, highlighting major updates
โข Classification of Medical Devices: Understanding the risk-based classification system in EU MDR
โข Clinical Evaluation and Investigations: Importance, requirements, and guidelines for clinical evaluation and investigations under EU MDR
โข Technical Documentation: Preparing, maintaining, and updating technical documentation in compliance with EU MDR
โข Unique Device Identification (UDI): Understanding the principles, requirements, and implementation of UDI system in EU MDR
โข Vigilance and Post-Market Surveillance: Implementing effective vigilance and post-market surveillance systems as per EU MDR
โข Notified Bodies and Conformity Assessment: Roles, responsibilities, and selection of Notified Bodies, as well as the conformity assessment process in EU MDR
โข Brexit and EU MDR: Impact of Brexit on EU MDR and implications for medical device manufacturers
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