Roadmap to Market step 5 - Software as a Medical Device
Roadmap to Market step 5 - Software as a Medical Device
Basic Level | Course | English | 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
Key2Compliance AB
Key2Compliance AB is an independent international organization providing its training and services to a variety of functions in the Life Science industry, from development to market in terms of Quality Systems and Regulatory compliance.
By helping organizations to comply with regulatory expectations, to enhance workforce knowledge and motivation and to promote a correct attitude towards quality, we believe we contribute to the supply of safe health care products - and in a wider perspective we save lives.
Trainer
Anna Lundén
Anna Lundén is one of the founders of Key2Compliance® and works in close contact with the Life Science industry with both training and consultancy. She has developed various training modules for many different levels of employees, from top management to line operators. She has long experience of working with European companies dealing with both EU and FDA requirements and expectations.
The course results in a diploma that shows that you have the skills required.
All prices shown exclude VAT.
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Online education is faster than traditional education. We make the same courses and content accessible in just under a third of the time normally required.
The efficiency gain is due to the fact that there are no lunch breaks, no commute, no group discussions, and no breaks. However, the total time spent teaching always remains intact.
1 h - Equivalent to a half-day course
2 h - Equivalent to an all-day course
4 h - Equivalent to a 2-day course
6 h - Equivalent to a 3-day course
Please note that the duration specified does not include time for breaks or revision. Don't forget to set aside time for any workshops and time to take the tests of the course, which is required to earn a diploma.
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