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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โข Regulatory Fundamentals
โข Understanding FDA Regulations
โข Biomedical Technology Submissions and Approvals
โข Quality System Regulation (QSR) and ISO 13485 Compliance
โข Design Controls for Biomedical Technologies
โข Risk Management in Biomed Tech
โข Clinical Trials and Data Management
โข Post-Market Surveillance and Compliance
โข Global Harmonization and International Regulations
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