Global Certificate in ISO 13485 for MedTech
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Course Details
• Introduction to ISO 13485 & Medical Devices
• Understanding ISO 13485 Requirements
• Risk Management in MedTech
• Quality Management System (QMS) Development
• Documentation Control for ISO 13485
• Training, Awareness, & Competence in MedTech
• Medical Device Design & Development Controls
• Manufacturing Process Controls & Validation
• Measurement, Analysis, & Improvement in ISO 13485
• Preparing for ISO 13485 Certification Audit
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