The Regulatory Manager course takes the student on a tour of the Saudi regulation. It looks at the regulations across the rest of the planet to place the requirements in context. To help the student with the more difficult aspects of the law, a sequence of modules dealing with individual subjects is delivered by specialists.
This comprehensive course comprises 14 modules broken into 36 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 250 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 28 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 5 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.
Biocompatibility of Medical Devices
Procedures for Regulatory Compliance
Clinical Investigation for Medical Devices and IVDs
Sterilisation of Medical Devices
This course covers the requirements for Sterilisation of Medical Devices under the Saudi Medical Device Regulation. On completion of this course, participants will have a strong foundational knowledge of the sterilisation requirements for Medical Devices.
Verification and Validation of Medical Devices
This course explores the verification and validation of processes. By the end of this course participants will be equipped with the basics of process verification and process validation.
Global Regulations
This course covers the Regulation for Medical Devices and IVDs around the world. By the end of this course participants will be equipped to understand medical device and IVD regulations in all the main territories on the planet.
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.
Medical Device Software
This course covers the requirements for Software in Medical Devices and Software as a Medical Device. By the end of this course participants will have a strong foundational knowledge of how to implement the regulations for software.
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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