Roadmap to Market Step 4 - Design and development

Roadmap to Market Step 4 - Design and development

Basic Level | English | Medical Device | 29 minutes

Corresponds to 2 hours of teacher-directed learning

Description

With this training you will get more insight in the requirements for controlling the development phase of a medical device. For low risk devices, focus are often mainly on that they are manufactured properly but as soon as they have a little bit higher risk to patient safety or include a Software, any company putting such a device on the market must control the development process as well. This training will give you a high level understanding of these requirements.

Content

  • Introduction
  • Why Design controls?
  • User perspective
  • From R&D to market
  • Terminology
  • Ready to manufacture?
  • Keys to success and summary

Course modules

0. Introduction

A short introduction of scope, content and learning objective. Introduction to the presenter.

Duration: 2 minutes (Total duration of the course: 29 minutes)

1. Why Design controls?

In this module, you will learn more about the reasons for why this phase is regulated and that even if the main reason is related to patient safety, it is also good business sense to work in a controlled way. We will discuss that the requirements are based on risk, that the company can choose any development model but that certain key requirements always must be fulfilled.

Trainer: Anna Lundén
Duration: 3 minutes (Total duration of the course: 29 minutes)

2. User perspectiveTry it!

In this module you will learn more about the important starting point for the development of a medical device – understanding how the product will be used, by whom and how their needs look like. You will learn about common processes to catch all these user needs and also a brief introduction to Useability engineering/Human factors.

Trainer: Anna Lundén
Duration: 4 minutes (Total duration of the course: 29 minutes)

3. From R&D to market

In this module, you will be introduced to how the requirement on development is structured in different steps, starting with requirements on written procedures and planning and going forward. You will learn about the necessity for a company to clarify when pure research ends, and development starts. We will also discuss how the development process generate all the data necessary to CE-mark your product or submit a 510(k) application to the FDA.

Trainer: Anna Lundén
Duration: 7 minutes (Total duration of the course: 29 minutes)

4. Terminology

After this module, you will be familiar with the terms used and some common challenges. We will cover Design input and Design output, Design verification versus Design Validation and other terms such as Design review, Design History File/Design and Development File and Design transfer.

Trainer: Anna Lundén
Duration: 4 minutes (Total duration of the course: 29 minutes)

5. Ready to manufacture?

In this module you will learn a bit more about the Transfer phase – the things needed to ensure all the product when transferred to production can be manufactured consistently with the right quality.

Trainer: Anna Lundén
Duration: 4 minutes (Total duration of the course: 29 minutes)

6. Keys to success and summary

A couple of words to summarise and connect back to the learning objectives. Some words on how to use the new knowledge, some key take-aways that you can try to remember in your future development projects.

Trainer: Anna Lundén
Duration: 5 minutes (Total duration of the course: 29 minutes)

Course material

There is no additional course material for this course.

Notes

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Training organisation

The course results in a diploma that shows that you have the skills required.


All prices shown exclude VAT.


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