Global Certificate in Medical Device Clinical Trials
-- ViewingNowThe Global Certificate in Medical Device Clinical Trials is a comprehensive course designed to meet the growing industry demand for experts in medical device clinical trials. This certificate equips learners with critical skills required to design, conduct, and manage clinical trials for medical devices, an area that has seen significant growth but faces a shortage of skilled professionals.
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โข Introduction to Medical Device Clinical Trials: Understanding the basics, phases, and regulations
โข Medical Device Regulations and Guidelines: FDA, EU MDR, ICH, and other international standards
โข Study Design and Protocol Development: Creating a robust and compliant study protocol
โข Ethics in Clinical Trials: Informed consent, patient safety, and institutional review boards
โข Clinical Investigation Planning: Site selection, budgeting, and contract research organizations
โข Data Management and Monitoring: Good clinical practice, electronic data capture, and safety reporting
โข Biostatistics in Medical Device Trials: Sample size calculation, statistical analysis plans, and hypothesis testing
โข Clinical Trial Results Analysis: Interpreting data, drawing conclusions, and preparing clinical study reports
โข Medical Device Regulatory Affairs: Navigating the regulatory landscape, pre-market approvals, and post-market surveillance
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