Outcome

The course gives a broad introduction to risk management according to the globally accepted standard ISO14971, and to the documentation needed to guide decisions and provide evidence of conformance.
 

Participants will understand

• How risk analysis may be carried out and structured to fit the particular product and its risks.
• How Risk Management can be incorporated into the Quality Management System, and how it interacts with e.g. Design Verification and Design Validation, Usability Engineering and biocompatibility evaluation.
• Purpose and content of key documents such as the Risk Management Plan and Report.
• Role of product and process standards regarding State of The Art and risk control.
• How to evaluate overall residual risk, assess the benefit risk balance and how to align with clinical evaluation.

Content

The course will shift back and forth between classroom training and interactive workshops. This will enable participants to work their way through the process steps, from identification of hazards, through risk analysis to risk control.
 
The course will provide pragmatic methods, tools and techniques, and discuss the most common pitfalls and how to avoid them.
Key standards interfacing risk management will be presented, such as IEC62366-1 Usability Engineering and ISO20417 Information Supplied By The Manufacturer.
 

Who should attend

The course is targeted professionals who are involved in the following areas:

• Development or maintenance of medical devices,
• Quality Assurance and Regulatory Affairs
• Project Managers

There are no pre-requisites but it is helpful to have experience from the medical device industry or other regulated industries.
 

Trainers

Peter Bøge, Design Control Specialist, Novo Nordisk A/S
Andreas Snitkjær, RA-QA Lead, Evido Health ApS