Global Certificate in Bioabsorbable Stents: Regulatory Affairs
-- ViewingNowThe Global Certificate in Bioabsorbable Stents: Regulatory Affairs course is a comprehensive program designed to provide learners with the essential skills and knowledge necessary to succeed in the rapidly evolving medical device industry. This course focuses on the regulatory aspects of bioabsorbable stents, which are increasingly being used as a safer and more effective alternative to traditional metallic stents.
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⢠Global Regulatory Landscape for Bioabsorbable Stents
⢠Bioabsorbable Stents: Definition, Classification, and Applications
⢠Design and Development Controls for Bioabsorbable Stents
⢠Preclinical Testing and Clinical Investigations for Bioabsorbable Stents
⢠Quality Systems and Good Manufacturing Practices for Bioabsorbable Stents
⢠Labeling, Instructions for Use, and User Training
⢠Risk Management and Evaluation for Bioabsorbable Stents
⢠Post-Market Surveillance and Vigilance for Bioabsorbable Stents
⢠Regulatory Submission and Approval Processes for Bioabsorbable Stents
⢠Global Harmonization and Convergence in Regulatory Affairs for Bioabsorbable Stents
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