Health2B in Oslo Science Park, Gaustadalléen 21, 0349 Oslo

In order to successfully create medical devices, you need to understand risk management.

Elevate your competence with this essential course for medical device companies, by joining our full day course.  At this full-day event, we help you dive in to the most important standard (ISO 14971:2019) for the application of risk management to medical devices.

Price:

• Norway Health Tech members: NOK 4 500, –
• Other: NOK 5 900, –

Course Description:

This course provides an orientation on the risk management process as per the EN ISO 14971:2019 standard. The focus is on risk analysis, evaluation, and risk control. Additionally, it explores the standard’s interplay with tools and techniques like FMEA (Failure Modes and Effects Analysis) and P-FMEA (Process Failure Modes and Effects Analysis).
The course is practical with examples and suitable for individuals involved in risk management, including R&D and QA engineers, product and application specialists, and clinical research specialists.
The objective of the course is to provide:
• Possess an understanding of the risk management process and its applications for medical devices.
• Comprehend the essential definitions employed in the risk management process.
• Gain insight into various techniques for risk analysis.

Trainers: Amrita Kaur and Mohammad Albatat, Yallow Life Science.

Agenda:

• 09:00 – Introduction: ISO 14971 Application of risk management to medical devices. Step by Step overview of the standard.
• 9:50 – Coffee Break.
• 10:00 – Sections 4,5: Risk Management Planning and Process.Practical examples and Tips.
• 10:50 – Coffee Break.
• 11:00 – Sections 4,5: Risk Management Planning and Process continued + Interactive exercise.
• 11:30-12:00 – Lunch
• 12:00 – Sections 6,7,8: Risk Control and Risk Evaluation
• 13:15 – Coffee Break
• 13:30 – Sections 9 & 10: Risk Management Review ; Production and Post Production Activities
• 14:15 – Coffee Break
• 14:30 – Risk management – interaction with other processes and Standards. Introduction to FMEA, as a risk management tool
• 15:00 – FMEA Exercise
• 15:30 – 16:00 -Quiz. Q&A and Closing Thoughts.