08:30 - 16:45
Meeting room HAGEN 1
This is a great opportunity to increase your knowledge in the area of Design Control. The Course will be run by the renowned Nordic instructor Peter Sebelius from Gantus.
The course will take place over 2 days and will cover all elements of Design Control. At the end of the course you will receive a certificate to prove that you have taken the course.
Maximum number of participants is 12.
Learning Goal and Contents
The learning goal is that participants should be able to work with product development in an organisation where design control is a requirement.
Introduction to Design control and key terms
The regulatory framework
Classification and product approval
Essential requirements, standards and guidelines
Using standards in medical device product development
Design and development inputs and traceability
How to manage requirements
Risk management and ISO 14971
Design phase and design output
Design verification and validation
The medical device files
The product approval process
What is enough?
Project process and repetition
For members NOK 8000 and NOK 10 000 for non-members for the full course, including course material, food & drink. Everyone is welcome, but there are only 12 spaces on the course. Members will be prioritized.
Delivery and what to expect
Gantus uses modern teaching techniques based on the latest educational science. Courses are evaluated during and at the end of the course to maximise the result.
The learning goal of the course is broken down into learning objectives. The course is divided into sections, each with its own set of learning objectives. The learning objectives will address key questions relating to effective design controls for medical devices. The course is interactive and engaging. There are interactive check-points at the end of each section to ensure that participants have achieved the learning objectives and ultimately the learning goal of the course.
The course focuses on how to work and why certain things should be done, as opposed to simply teaching the requirements. Slides that contain only bullet points or long texts are kept to a minimum throughout the course. Participants will receive hard copies of the slides.
Upon completion of the course, a report will be compiled containing the course evaluation.
Please register as soon as possible – we can only accept 12 participantsRegister