Design Control training with Peter Sebelius/Gantus

22 May
08:30 - 16:45

Forskningsparken
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.

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

Register

Speakers

Peter Sebelius

Gantus - Peter Sibelius

info@gantus.se