HI-MT4 Software as Medical Device - Getting started with CE Certification

A practical guide on the application of MDR requirements for Medical Device Software.

Training information

1 day
18 March 2025

Investment

The investment for the One Day Training is €795 per participant, excluding VAT.

Included is the training day, course material, lunch, and refreshments.

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Talk to our academy advisor

About the course Medical Device Software Development.

Compliance of your medical device software to EU regulations is certainly not something you would do on a Friday afternoon, but it is often underestimated, especially now the regulations have been updated to the MDR.

You need amongst others to classify your software, determine the applicable requirements and standards, plan your software development, perform risk assessments, test your software, perform usability tests and provide documented evidence.

This newly developed one-day training will give you an overview of the applicable regulation and standards for Medical Device Software and will provide you with practical knowledge on how to apply the requirements of the MDR (Medical Devices Regulation) and the applicable standards in your software development process.

With this course you’ll learn:

Software life cycle processes according to IEC 62304
Safety Risk Management according to ISO 14971
Usability Engineering according to IEC 62366-1
Agile practices

Teaching professionals.

Nico van Oene

QA/RA Consultant

Nico is a QA/RA consultant with several years of experience in software development for medical devices. He has over 30 years of experience in software engineering in various roles (software engineer, project manager, Scrum Master, QA officer, process improvement) and in different domains. Currently, Nico supports software projects on QA/RA aspects and provides consultancy to medical companies on software development-related topics. He is highly motivated to help people and organizations grow professionally. Conducting workshops allows him to share his knowledge with others.

Training: Software as Medical Device - Getting started with CE Certification.

Outcome

Over the last years, medical devices increasingly contain software. Also more and more stand-alone software for medical applications, like apps and decision support software, is launched in the market. In most cases, such software needs to comply with the requirements of the EU Medical Devices Regulation (MDR) when it will be marketed within Europe.

The Software as Medical Device - Getting started with CE Certification training will give you an overview of the applicable regulation and standards for Medical Device Software and will provide you with practical knowledge on how to apply the requirements of the MDR (Medical Devices Regulation) and the standards in your software development process.

Software as Medical Device - Getting started with CE Certification

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What you’ll learn.

Program

When does the software need to comply to the MDR?
Classification of Medical Device Software
Summary on CE certification and when do you need a Notified Body?
Determine applicable Safety and Performance Requirements and Standards
Quality Management System based on ISO 13485 for a software company

Practical information.

For whom

The training is suited for

Medical Device software engineers, project managers, product managers, testers, quality and regulatory engineers.
Management of medical device software manufacturers and suppliers

The training is suited for professionals with a master or bachelor level, or equivalent knowledge gained through experience.

Certificate

Participants who have followed the full course receive a certificate of participation.

After the training, holland-innovative optionally offers on-the-job coaching to further improve and implement the medical device development process and practices in your company. This course can also be given within your company, tailored to your specific needs.

The course can be extended with topics, like:

CE certification of medical device
Project Management

Location & Dates

Locations
Eindhoven – High Tech Campus 29
Enschede – Hengelosestraat 500 (Building The Gallery)
Zeist - Utrechtseweg 48

Dates 2025
Session I: 18 March

Session II: 9 September

Group size

A maximum of 10 participants

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