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Risk management for medical devices and ISO 14971

Gantus AB
2 days
1 340 EUR excl. VAT
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Description of Risk management for medical devices and ISO 14971

The goal of the course is that you should be able to work with risk management. The course focuses on the parts where you spend most of the time; risk analysis, evaluation and risk control. It is a practical course with focus on how to do things, rather than just requirements or principles from the standard. The course is appropriate for anyone working with risk management, such as R&D Engineers, product specialists and the Quality Assurance department. It is also appropriate for people with a need to understand the requirements and principles of risk management, such as management, internal auditors, regulatory affairs and customer service. The course is packed with practical work that ensures you actually get to try your skills both in groups and individually. The number of participants is limited to 12.

The course also includes an orientation on ISO 14971 risk management's relation to tools and techniques such as FMEA, P-FMEA and FTA


The course comprises lectures, interactive check-points and workshops. The instructor will follow up on learning objectives throughout the course. This means that participants will have to answer questions on the topics covered to ensure that the objectives are met. Active participation and at least 75% attendance is required to be eligible for course certificates.
The course is conducted in English.

Purpose and learning goal

The learning goal is that participants should be able to perform risk management work for non-complex medical devices according to the requirements of ISO 14971.

Who should attend

Instruction is targeted towards professionals who are involved in the following areas: 

- the development of medical devices
- quality assurance
- auditing of medical device companies

Recommended prerequisites

There are no pre-requisites for this course.


Day 1
What is risk management
Why risk management
Standards relating to risk management
The general requirements of risk management
Annex Z
Risk analysis
Risk evaluation
Risk control

Day 2
Risk management tools and techniques
Overall residual risk evaluation
Risk management report
Production and post-production information


The course fee is 1,340 EUR including lunch and course material (excl. VAT and living expenses). 


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Gantus AB

Gantus AB

Gantus AB

Gantus ger kurser inom medicinteknik, såsom design control, riskhantering, projektledning för produktutveckling av medicintekniska produkter och kvalitetsledning. Samtliga kurser ges av Peter Sebelius som har mångårig erfarenhet av både utveckling av medicintekniska produkter och att få dem godkända på de...

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