Executive Development Programme in MDR Documentation
-- ViewingNowThe Executive Development Programme in MDR Documentation is a crucial certificate course designed to meet the growing industry demand for experts in Medical Device Regulation (MDR). This comprehensive programme imparts essential skills required to excel in MDR documentation, a critical aspect of medical device development and marketing.
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โข MDR Fundamentals: Overview of Medical Device Regulation, key terminology, and regulatory framework
โข Classification of Medical Devices: Understanding the risk-based classification system for medical devices
โข Quality Management System: Implementing and maintaining a compliant Quality Management System (QMS)
โข Technical Documentation: Preparing and managing technical documentation, including Design Dossiers and Technical Files
โข Clinical Evaluation: Conducting clinical evaluations and preparing Clinical Evaluation Reports (CERs)
โข Post-Market Surveillance: Implementing and managing post-market surveillance and vigilance processes
โข MDSAP & International Regulations: Understanding the Medical Device Single Audit Program (MDSAP) and global medical device regulations
โข UDI & Traceability: Implementing Unique Device Identification (UDI) and traceability systems
โข Notified Bodies & Conformity Assessment: Working with Notified Bodies and navigating the conformity assessment process
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