Executive Development Programme in MedTech Regulatory Transformation Strategies
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Course Details
• MedTech Regulatory Environment Overview
• Global Harmonization and Convergence Initiatives in MedTech Regulations
• Understanding ISO 13485:2016 and its Role in MedTech Quality Management Systems
• European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)
• Navigating the US FDA Regulatory Landscape for MedTech Products
• Post-Market Surveillance and Vigilance in MedTech Regulatory Strategies
• Leveraging Digital Health Technologies and Data in MedTech Regulatory Transformation
• Strategic Approaches to MedTech Regulatory Submissions and Approvals
• Managing Compliance Risks and Building a Culture of Ethics in MedTech Organizations
Career Path
Entry Requirements
- Basic understanding of the subject matter
- Proficiency in English language
- Computer and internet access
- Basic computer skills
- Dedication to complete the course
No prior formal qualifications required. Course designed for accessibility.
Course Status
This course provides practical knowledge and skills for professional development. It is:
- Not accredited by a recognized body
- Not regulated by an authorized institution
- Complementary to formal qualifications
You'll receive a certificate of completion upon successfully finishing the course.
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