Certificate in EU Medical Device Regulations Overview
-- ViewingNowThe Certificate in EU Medical Device Regulations Overview is a comprehensive course designed to provide learners with a solid understanding of the EU medical device regulatory landscape. This course highlights the importance of EU MDR in ensuring patient safety and product compliance, making it essential for professionals working in or seeking to enter the medical device industry.
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Here are the essential units for a Certificate in EU Medical Device Regulations Overview:
- โข EU Medical Device Regulations (MDR) Overview
- โข Classification of Medical Devices in the EU
- โข Technical File Requirements for EU MDR
- โข Clinical Evaluation and Investigations
- โข EU MDR Conformity Assessment Procedures
- โข EU MDR Labeling and UDI Requirements
- โข Post-Market Surveillance and Vigilance in the EU
- โข EU MDR Notified Bodies and Authorized Representatives
- โข Brexit and its Impact on EU Medical Device Regulations
- โข Case Studies and Best Practices for EU MDR Compliance
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