Degree:

Specialized Professional Training Certificate.

Target Audience:

  • Quality Managers.
  • Biomedical Engineers.
  • Production Supervisors.
  • Personnel working in medical device manufacturing or maintenance.

Program Description:

This specialized training program aims to enable participants to understand and apply the ISO 13485 Quality Management System for medical devices. The program covers the fundamental principles of the system, risk management, regulatory requirements, preparation of technical documentation, quality control, and internal and external auditing throughout the device lifecycle.

Program Duration / Hours:

  • Total: (80) training hours.
  • Theoretical: (28)hours.
  • Practical: (40) hours (70% practical training).

Training Mode:

  • Workshops
  • Hands-on practical applications.
  • Case study analysis.

Training Language:

Arabic, supplemented with international English terminology.

Admission Requirements:

Background in engineering, quality management, or medical manufacturing.

Learning Outcomes:

  • Understand the principles and components of the ISO 13485 quality management system for medical devices.
  • Develop and implement risk management and quality control procedures.
  • Design a comprehensive documentation system according to ISO 13485 standards.
  • Apply requirements for internal auditing and review.
  • Ensure compliance with regulatory requirements for manufacturing and importing medical devices.

Career Opportunities after the Program:

  • Quality Coordinator in a medical device manufacturing facility.
  • Compliance and International Standards Manager.
  • Quality Audit Specialist.
  • Consultant for developing medical quality management systems.

Scientific Supervision:

The program is supervised by Midmak International Academy – Syria | Australia, recognized as an international authority accredited by the American Board of Medical and Health Specialties.

Assessment:

  • Gap analysis project for an existing quality system.
  • Practical test on preparing a compliance document according to the standard.

Certificates Awarded:

  • Professional certificate issued by the American Board, verified by the U.S. government and accessible through their verification system Dataflow.
  • Professional Qualification Certificate: Issued by Midmak International Academy – Syria | Australia, certified by both the Australian and Syrian Ministries of Foreign Affairs.
  • Academic Documentation: From the American University for Continuing Medical Education (AU-CME).

Advancement Opportunities:

Participants may continue with an ISO 9001 Integrated Medical Quality Management Fellowship or advanced quality management programs.