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This course has been designed to help individuals build up a solid and a comprehensive framework in the medical device’s regulatory affairs, and to provide a basic understanding of the medical devices including IVDs., addressing market information, technical documents, and guidelines of the related authorities in MENA region.
We are a leading provider of professional trainings for the medical and pharmaceutical industry. Relying on our extensive training portfolio with expert instructors and recognized certifications. If you want to understand the rules that govern the Regulation of medical devices in the middle east Market place this course is perfect for you.
Why to join this Course?
Who Should Attend?
This course is ideal for medical or science bachelor degree holders who would like to start their RA career in medical devices and for newly joined employees to the RA departments in a medical device company, it can also be useful for the below:
Experience / Prerequisite Experience
This course doesn’t require previous experience in regulatory affairs; however, it requires a relevant experience/ knowledge and/ or a bachelor’s degree in the pharma, biomedical engineering, pharmaceutical science, or any medical background which qualifies you to benefit from the training.
We also consider applicants with different background on a case-by-case basis.
Course Modules | |
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Introduction to Medical Device (IVDs). | |
EU Medical device regulations / (IVDs)( MDD and new MDR). | |
GCC Medical Device registration (part 1) – KSA. | |
GCC Medical Device registration ( Part2) – UAE , Oman , Bahrain , Qatar, and Kuwait. | |
Egypt and Sudan Medical devices regulation. | |
Morrocoy, Algeria, Libya, and Tunisia Medical device regulations. | |
Levant Medical device regulations(Syria, Jordan, Palestine, Lebanon, and Iraq). | |
Materiovigilance in EU & and QSR in ME. |