08:30 - 16:45
Forskningsparken
Meeting room HAGEN 1
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.
Tentative programme:
| Day 1
08:45-16:45 |
Day 2
08:45-16:45 |
|
| Introduction
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
|
Usability engineering
Design planning Design review Design phase and design output Design transfer Design verification and validation The medical device files The product approval process What is enough? Design release Change control Documentation pitfalls Project process and repetition
|
Costs:
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 participants
Påmelding