Learning goals:

• Understand what basic safety for a medical device is.
• Understand why and how basic safety is implemented and the most common pitfalls in medical device product development and how to avoid them.
• Strengthen your communication skills in the area of basic safety for medical devices.
• Build awareness of effective management of safety throughout the product lifecycle.

Learning goals:

• To understand the overall process of risk management and how to create safe medical devices.
• To strengthen the ability of participants to independently perform risk analysis, risk evaluation and risk control.
• To establish and increase knowledge on risk management tools and their differences, such as FMEA and P-FMEA.

Course content:

• Introduction
• Medical devices - EU
• Combination products
• Quality system strategy
• Design Controls
• Planning
• User needs -> Design input
• Risk management
• Design Output
• Design Review
• Design Verification
• Design Validation
• Design Transfer
• Design Changes
• Design Documentation ”DHF”