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

At The End Of The Course You Will Be Able To

• Understand the different standards for the packaging and labeling design in the medical devices industry.
• Comprehend the established requirements by the regulatory organizations for the packaging and labeling design in the medical device industry.
• Understand the expected outcome from the packaging and labelling design process and the input required to properly perform this process.
• Compare the different sterilization options accepted by the standards and regulatory organization and understand the related packaging design considerations.
• Learn how the tests distribution represents a challenge for packaging design in the medical device industry.
• Identify the packaging materials options and their implications for the device protection and manufacturing process.

Course Content

1. Overview and Quality System (ISO 11607)
2. Regulations (EU MDR)
3. ASTMs and ISTA Standards
4. Design Inputs – Outputs
5. Sterilization
6. Distribution Testing
7. Packaging Materials
8. Packaging Process, Labeling & UDI.