- Introduction (00:05:43)
- Regulatory References (00:02:36)
- General Safety and Performance Requirements (00:04:25)
- Expert Panel and Relevant Evidence (00:03:58)
- Clinical Investigations and Equivalence (00:04:54)
- Clinical Evaluation Updates and Clinical Evaluation Report (00:06:08)
- Clinical Evaluation Plan Content (00:04:52)
- Criteria for Equivalence and Results (00:01:38)
- Consultation and Scrutiny (00:06:04)
- MDR Periodic Deliverables (00:01:31)
Clinical Evaluation Upgrade to MDR
Is your Clinical Evaluation ready for the MDR? Discover Meditrial e-learning and avoid delays for market access. Meditrial will guide you with easy steps. Learn at your own pace and reach your goals!
After the course, you can take a brief test to receive your certification. Enjoy!
Why take this course
This Meditrial Recorded Video Lecture by Dr. Monica Tocchi is designed to support manufacturers by providing the information necessary to get a CE mark or upgrade the clinical evaluation to MDR in order to confirm a CE mark for medical device. Find out how to produce a high-quality clinical evaluation report (CER) that is acceptable to the regulatory authorities and Notified Bodies for all your medical devices.
What I will learn
- Clinical evaluation regulatory framework
- Overview of Article 61 of MDR
- General Safety and Performance Requirements
- How to conduct Clinical evaluation: Step by Step
- Notified Body Clinical Evaluation Assessment Report (CEAR)
- What are your periodic deliverables?
Skills I will gain
- Understand the clinical evaluation process
- Learn about the new GSPR and their relevance for medical devices assessment
- Determine which data you need to support the assessment of your device (clinical investigation, literature review, equivalence)
- Assist your organization in setting a strategy for a successful clinical evaluation
- Final Test – Clinical Evaluation Upgrade to MDR
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