The Clinical Specialist course takes the student on a tour of the clinical requirements of the Saudi regulation. It focuses on Clinical Evaluation, Performance Evaluation, Clinical Investigation and Risk. Individual subjects in the course are delivered by specialists.
This comprehensive course comprises 6 modules broken into 15 lectures. Each module will include a one hour tutorial where you may ask any questions of the lecturer which occur to you after you have completed the module. For a description of the modules, click on the ‘Download Brochure’ button above.
This course requires approximately 100 study hours. There is an introduction to the course where you will be given instructions on how to access the student portal and an overview on how the course will run. This includes 12 hours of assignments and a three hour exam. It is delivered live and on-line, and lectures include exercises conducted in groups, pairs or individually.
Students are expected to commit to an average of 2 hours study per week and are also expected to be fluent in English, both spoken and written, and registered with the Academy Centre in Riyadh.
All students must have EITHER a recognised degree, or higher, OR at least three years experience in Regulatory Affairs.
Introduction to the Saudi Regulation for Medical Devices and IVDs
This course introduces the Saudi Regulation for Medical Devices and In Vitro Medical Devices (IVDs). By the end of this course participants will have a strong foundational knowledge of the Saudi Arabian regulations.
Clinical Investigation for Medical Devices and IVDs
Introduction to Post-Market Surveillance and Vigilance of Medical Devices
This course deals with post-market activities for medical devices. By the end of this course participants will be equipped to conduct various post-market surveillance activities.
Performance Evaluation of In Vitro Medical Devices
This course covers the requirements for Performance Evaluation of Medical Devices. By the end of this course participants will have a strong foundational knowledge of the Performance Evaluation of In Vitro Medical Devices.
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Clinical Evaluation of Medical Devices
This course covers the requirements for Clinical Evaluation of Medical Devices. On completion of this course participants will have a strong foundational knowledge of the Clinical Evaluation.
The Risk Analysis of Medical Devices
This course covers the requirements for Risk Management of Medical Devices and IVDs. By the end of this course participants will have a strong foundational knowledge of how to conduct an effective Risk Analysis.
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