Learning goals:

• Know how to create high quality software
• Know how to create safe software
• Be able to manage software in a way that adds value to you

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:

• EU Medical Device Regulation (MDR)
• FDA regulations
• Good practice: SW lifecycle processes
• 60601 with focus on chapter 14, contribution of SW to essential performance
• 62304 - Software development lifecycle
• Development For class C software
• Software risk in relation to 62304
• Concept cybersecurity
• Cybersecurity risk management process
• Agile SW development
• GDPR/HIPAA
• Tool validation

Course content:

• Medical devices - EU
• Combination products
• Quality system strategy
• Design Controls
• Planning
• User needs -> Design input
• Risk management
• Design Output, Review, Verification, Validation, Transfer, Changes
• Design History File