Masterclass Certificate in Biomedical Product Testing: Quality Control
-- ViewingNowThe Masterclass Certificate in Biomedical Product Testing: Quality Control is a comprehensive course that equips learners with critical skills for career advancement in the biomedical industry. This certificate program emphasizes the importance of rigorous testing and quality control in biomedical product development, ensuring the production of safe and effective medical devices and pharmaceuticals.
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⢠Fundamentals of Biomedical Product Testing: An introduction to the principles and practices of biomedical product testing, including quality control methodologies.
⢠Regulatory Compliance in Biomedical Product Testing: A unit covering the various regulations and guidelines that govern biomedical product testing, including FDA, ISO, and EU MDR requirements.
⢠Biocompatibility Testing: An exploration of the methods and procedures used to evaluate the biocompatibility of medical devices, including cytotoxicity, sensitization, and intracutaneous reactivity tests.
⢠Biomechanical Testing: A unit focused on the biomechanical testing of medical devices, including fatigue testing, dynamic testing, and static testing.
⢠Clinical Testing and Validation: A discussion of the clinical testing and validation of medical devices, including study design, data analysis, and reporting.
⢠Quality Control in Biomedical Product Manufacturing: An examination of the quality control measures used in biomedical product manufacturing, including statistical process control, quality assurance, and continuous improvement methodologies.
⢠Quality Management Systems for Biomedical Products: A unit covering the implementation and management of quality management systems for biomedical products, including ISO 13485 and FDA QSR requirements.
⢠Risk Management in Biomedical Product Testing: A discussion of risk management principles and practices in biomedical product testing, including hazard analysis, risk assessment, and risk control.
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