Executive Development Programme in Biomedical Tech: Regulatory Affairs
-- ViewingNowThe Executive Development Programme in Biomedical Tech: Regulatory Affairs is a certificate course designed to provide learners with critical skills in regulatory affairs, a vital function in the biomedical industry. This programme emphasizes the importance of regulatory compliance, ensuring the safety and efficacy of biomedical products, and facilitating their market access.
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ใณใผใน่ฉณ็ดฐ
โข Regulatory Landscape & Compliance
โข US FDA Regulations for Biomedical Tech
โข EU MDR/IVDR Regulations & Compliance
โข Global Harmonization & International Standards
โข Clinical Trials & Data Management
โข Product Submission & Approval Processes
โข Quality Management Systems (QMS) & ISO 13485
โข Post-Market Surveillance & Vigilance
โข Risk Management & Hazard Analysis
โข Strategic Regulatory Affairs for Business Growth
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