The course focuses on providing the student with a robust knowledge of design controls for medical devices according to international regulations and standards.

Throughout the course, students will engage in hands-on learning experiences, applying their knowledge of the design control process (planning, inputs/outputs, review, verification and validation) in the medical device industry, ensuring regulatory compliance and addressing real-world challenges.

At The End Of The Course You Will Be Able To

• Understand the steps and controls that involves  the medical devices design.
• Associate the steps in the medical devices design process to the regulation and standard´ requirements.
• Articulate an appropriate design process for a medical device.
• Assess changes proposed to a medical device, based on the regulation´s and standards´ requirements.

Course Content

1. General Process Overview
2. Design Planning
3. Design Input/outputs
4. Design Review
5. Design Verification
6. Design Validation
7. Design Transfer
8. Design History Files
9. Design Changes