Quality Manager

ر.س28,165.00

Aimed at medical device quality professionals who have a business or a department to run, this course covers Quality Management Systems from introduction to design of procedures and auditing.

This PRQ (Professional Regulatory Qualification) provides a TVTC accredited certificate and is taken over a full year.  The course is run by highly skilled tutors, including those with Notified Body (CE) and Competent Authority (SFDA) experience, and is both practical and flexible.

 

The Quality Manager course takes the student through all aspects of Quality Management for Medical Devices. It begins with an introduction to the ISO 13485 standard and works through to auditing quality systems. The student will learn how to construct a Quality Management System to ISO 13485 and how to write procedures. The course provides an introduction to the Saudi Regulation with modules specific to the Essential Principles and Post-Market activities for Medical Devices. It is intended that a student should finish the course well versed in how to manage a Quality System for a medical device company.

This comprehensive course comprises 6 modules broken into 18 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 10 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.

Procedures for Regulatory Compliance

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.

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.

Introduction to ISO 13485 (Clause by Clause)

This  course takes you step by step through the standard. By the end of this course participants will have a strong foundational knowledge of the quality management system requirements.

Internal Auditor for ISO 13485

This course covers the requirements for auditing under the ISO 13485 standard. By the end of this course, participants will have a strong foundational grounding in auditing Medical Devices to the harmonised standard.

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+966 (11) 463 308

Course Ref:
PRQ002

Call us today to find out more information / book:
+966 (11) 463 308
Use course code: PRQ002

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