Roadmap to Market step 5 - Software as a Medical Device

Roadmap to Market step 5 - Software as a Medical Device

29 minutes

Corresponds to 2 hours of teacher-directed learning

Description

With this training (Step 5) you will get more insight in the general requirements for Medical Device Software.

Content

  • Introduction
  • Embedded Software - SW in a Medical Device
  • Standalone Software
  • How to know if it is a medical device?
  • Overview of requirements
  • Risk management and classification
  • Key considerations
  • 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. Embedded Software - SW in a medical device

In this module, you will learn more how software embedded in a physical medical device are handled from a regulatory perspective. We will discuss that the requirements are based on risk, but any software used must be safe and suitable for the intended purpose. You will also hear a little bit about how this is connected to Design and development validation.

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

2. Standalone Software

In this module you will learn more about all different kinds of health-related software that are offered as stand-alone packages, i.e. as applications for different platforms, decision support tools, and systems used to transfer data. You will also get a high level understanding about how the regulatory landscape affects these different types of software. This module includes examples of standalone software.

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

3. How to know if it is a Medical Device?

In this module, you will be familiar with the guidance documents and tools that you can use to understand if a specific software is qualified as a Medical Device or not.

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

4. Overview of requirements

Here you will learn more about the concept of ”validating” the software and you will get more information about the two most important standards used for this purpose (IEC 62304 Medical device software - Software life-cycle processes and IEC 82304-1 Health software - Part 1: General requirements for product safety). You will also learn how these standards fit with both EU and US regulatory requirements.

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

5. Risk management and classification

Now we will get more into the concept of risk management, and you will be introduced to how software is classified based on risk. You will learn about software safety classification according to IEC 62304, the software lifecycle standard and look at potential applicable classification rules according to MDR. This module includes some examples of SW classification of different types of MDSW.

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

6. Key considerations

In this module you will learn more about both some key aspects related to Software used in the health industry – a starting point for a plan going forward with a MDSW project or existing MDSW.

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

7. Summary

A couple of words to summarise and connect back to the learning objectives.

Trainer: Anna Lundén
Duration: 1 minute (Total duration of the course: 29 minutes)

Course material

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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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