Risk Management for Medical Devices according to ISO14971
This two-day course provides hands-on methods for managing the risk of harm to patients, users and others, in development and maintenance of medical devices.
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. These 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, and
- Project Managers
There are no pre-requisites, but it is helpful to have experience from the medical device industry or other regulated industry.
Trainers
Peter Bøge
Design Control Specialist, Novo Nordisk A/S
Peter Bøge is a medical device design control specialist with extensive experience in ISO and IEC standardisation of risk management, usability engineering and labelling development. On this course, he guides participants through the complete ISO 14971 process – from hazard identification and risk analysis to risk control, evaluation of residual risk and production and post-production activities. He places particular emphasis on integrating risk management with design control, usability engineering, verification, validation and other regulatory documentation.
Andreas Snitkjær
RA-QA Lead, Evido Health ApS
Andreas Snitkjær began his career as a risk manager before moving into the intersecting fields of systems engineering, quality and regulatory compliance for medical devices. On this course, he helps participants apply ISO 14971 through pragmatic methods and tools, including the preparation and maintenance of risk management plans, analyses and reports. His perspective connects the standard’s requirements with practical product development and the ongoing maintenance of a medical device quality system.
What previous participants said
Contact
Select date
26-27 november 202615-16 november 2027
26-27 November 2026 - at 09:00 - 16:00
Price ex. VATLatest Registration
23 November 2026
Latest Cancellation
5 November 2026
Bøge Allé 5, 2. th
2970 Hørsholm
Terms
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Berit Munkebo
Head of Development
bm@medicoindustrien.dk
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