Professional Certificate in Biomed Tech: Regulatory Mastery
-- ViewingNowThe Professional Certificate in Biomed Tech: Regulatory Mastery is a comprehensive course that equips learners with critical skills in regulatory affairs for biotechnology products. This program is vital in an industry where adhering to strict regulatory standards ensures product safety and company compliance.
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⢠Regulatory Fundamentals
⢠Understanding FDA Regulations
⢠Biomedical Technology Submissions and Approvals
⢠Quality System Regulation (QSR) and ISO 13485 Compliance
⢠Design Controls for Biomedical Technologies
⢠Risk Management in Biomed Tech
⢠Clinical Trials and Data Management
⢠Post-Market Surveillance and Compliance
⢠Global Harmonization and International Regulations
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