Risk management analysis, using (EN) ISO 14971 (2 days with an exam)

Course description:

This is a two-day intensive course designed to provide participants with a thorough understanding of the impact of ISO 14971 on the decision-making process of medical device manufacturers throughout the life-cycle of their product. It examines various methodologies and strategies for both risk analysis and management. The use of FMEA (Failure Mode and Effects Analysis) or FTA (Fault Tree Analysis) in identifying hazards, their severity and the probability that they might occur, are considered. Control measures and the monitoring of the effectiveness of such controls are discussed. The relationship of ISO 14971 to ISO 13485 in relation to EU/MDD product regulations is considered, as are the requirements of the FDA/QSR.

Using a variety of case studies, hypothetical devices, or participant’s actual devices, the practical application of the principles of risk analysis will be, interactively demonstrated, discussed and reviewed.

At the end of the two days, participants will be required to show that the have acquired the relevant know-how and skills by taking a short exam.

Course Objectives:

• To provide participants with a thorough understanding of the role of risk management in the Medical Device Industry
• To (re)acquaint participants with the latest EU and FDA requirements regarding risk management
• To provide participants with a comprehensive overview of ISO 14971
• To give participants the practical tools for implementing ISO 14971
• To recognize the application of ISO 14971 to ISO 13485
• To understand the importance of management participation in the risk management process and risk management planning
• Identification of possible areas of liabilities and unforeseen costs

Who should attend:

This course is intended for participants who already have some knowledge of quality and risk management in the medical device industry such as:

• Regulators
• R&D Managers
• QA/RA Managers
• Production Managers
• Senior Management in Operations, Regulatory and Quality management

Course Materials:

Participants will receive a comprehensive course manual with reference materials, and upon successful completion of the course and the exam, a “certificate of attendance and satisfactory completion”.

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