Postgraduate Certificate in Clinical Evaluation for Medical Devices
-- viewing nowThe Postgraduate Certificate in Clinical Evaluation for Medical Devices is a comprehensive course designed to equip learners with the essential skills needed to excel in the medical device industry. This certificate program emphasizes the importance of clinical evaluation in ensuring the safety and performance of medical devices, making it highly relevant and in-demand in today's rapidly evolving medical landscape.
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Course details
• Clinical Evaluation Basics: Introduction to clinical evaluation, regulatory requirements, and clinical evaluation reports (CER)
• Medical Device Classification: Understanding medical device categories and their impact on clinical evaluation requirements
• Literature Review and Search Strategies: Techniques for conducting comprehensive literature reviews and search strategies for clinical data
• Clinical Evaluation Planning: Designing and planning clinical evaluations, including objectives, study types, and methodologies
• Clinical Data Analysis: Evaluating and interpreting clinical data, statistical analysis, and drawing conclusions
• Clinical Evaluation Report Writing: Guidelines for structuring and writing CERs, complying with regulatory standards, and ensuring completeness and accuracy
• Post-Market Clinical Follow-up: Post-market clinical surveillance, monitoring, and data collection for continuous evaluation and improvement
• Clinical Evaluation Challenges and Best Practices: Addressing common challenges, ethical considerations, and best practices in clinical evaluation for medical devices
• EU MDR and IVDR Impact: Exploring the impact of the European Union Medical Device Regulation (EU MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) on clinical evaluation requirements
• Emerging Trends and Technologies: Examining the impact of new and emerging medical device technologies on clinical evaluation practices and requirements
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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