Masterclass Certificate Medical Device Development
-- ViewingNowThe Masterclass Certificate in Medical Device Development is a comprehensive course designed to equip learners with essential skills for success in the medical device industry. This program focuses on the entire process of medical device development, from ideation and design to regulatory approval and market launch.
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โข Medical Device Regulations: Understanding FDA and EU MDR/IVDR regulations, ISO 13485, and quality management systems
โข Medical Device Design Control: Applying design control principles and requirements for medical device development
โข Risk Management in Medical Device Development: Implementing ISO 14971 and conducting risk assessments
โข Human Factors Engineering: Incorporating human factors in medical device design and usability testing
โข Biocompatibility and Material Selection: Evaluating materials for medical device applications and understanding biocompatibility requirements
โข Prototyping and Pre-clinical Testing: Designing prototypes, conducting bench testing, and preparing for pre-clinical studies
โข Clinical Trials and Data Analysis: Planning, executing, and analyzing clinical trials for medical devices
โข Medical Device Regulatory Submissions: Preparing and submitting 510(k), PMA, and EU MDR technical files
โข Medical Device Post-market Surveillance: Managing post-market surveillance, MDR reporting, and complaint handling
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