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Are you struggling to navigate the clinical evaluation requirements under the EU MDR? Has your notified body given you feedback that you do not know how to deal with?
Our Medical Device Clinical Evaluation training course will help you to understand and equip you with the knowledge, skills, and expertise required to conduct rigorous and compliant clinical evaluations of medical devices.
Throughout this training, we delve into the core principles and practices that underpin effective clinical evaluations, while addressing the latest regulatory requirements, real world examples and best practices in the field.
What is Clinical Evaluation?
Definitions and Key Terminology
Clinical Evaluation Process
Clinical Evaluation and the MDR
Links to other processes
Clinical Evaluation Plan
State of the Art
Safety and performance outcome parameters
Literature Search & Databases
Develop your question – PICO
Identification of Data
Appraisal & Analysis
Risk of Bias
Clinical Evaluation Report
Determining sufficient evidence
Post Market Clinical Follow-up (PMCF)
Summary of safety and clinical performance (SSCP)
Clinical evaluation guidance
Notified Body perspective
– 4 half days of live online training
– Copy of the presentation
– Host of additional materials
– PDF Certificate of completion
– Join in polls, tests and breakout rooms
– Q&A session
What you need:
▪ Access to Zoom
▪ Access to a microphone (Webcam not required)
Who should attend?
This course applies to anybody that requires an understanding of clinical evaluation and provides you with a solid foundation.
Audience learning level: Basic to intermediate
Discounts are available for 3+ attendees. Please email us at firstname.lastname@example.org for your unique discount code to use at the checkout.