HI-MT3 One Day Training Medical Device Software

A practical guide on the application of MDR requirements for Medical Device Software | 1 day

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 One Training Medical Device Software 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.

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About the One Day Training Medical Device Software

Compliance of your medical device software to EU regulations is certainly not something you would do on a Friday afternoon, but 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.

Subjects of the One Day Training Medical Device Software

The following topics will be discussed during the training:

  • When does the software need to comply with 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

Results of the One Day Training Medical Device Software

During the training you will 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

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 are able to take the course. Professionals with a master or bachelor level, or equivalent knowledge gained through experience.

Setup training

The training consists of 1 day from 9 am to 4 pm.

Date, locations & schedule

Location: Eindhoven – High Tech Campus 29
Location: Enschede – Hengelosestraat 500 (Building The Gallery)

Dates 2021
Location: Eindhoven
September 23

Investment training

The investment for the One Day Training is €795 per participant, excluding VAT. Included is one interactive training day and paper course material, which will be sent to you in advance.


Jolande Koobs
Experienced Project Manager with a demonstrated history of working in the medical device industry. Project management professional and Regulatory specialist skilled in managing the development of (software) products with a strong affinity for Quality assurance and Regulatory affairs.

Certificate/ diploma

Participants receive a certificate of participation.

Method of teaching

The training is offered as an in-class course, but any other form is open for negotiation. We are able to offer offline, online and hybrid courses. In the case of one or more non-Dutch speaking participants, the course is given in English

Group size

Maximum group size: 10

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

Persoonlijk opleidingsadvies?

Wilt u graag meer informatie over deze opleiding? Onze deskundige opleidingsadviseurs helpen u graag verder! Zij zijn telefonisch bereikbaar van maandag t/m vrijdag van 08.30 tot 17.00.

T: +31 (0)40 851 4610
E: academy@holland-innovative.nl

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Over de Holland Innovative Academy

Holland Innovative helpt bij het ontwikkelen van de competenties van u en uw collega’s om uw organisatie te versterken en groei te creëren. Samen met gerenommeerde expertisecentra zoals de Technische Universiteit Eindhoven, Universiteit Twente, Technische Universiteit Delft en de Universiteit van Stuttgart organiseren we opleidingen, trainingen en masterclasses in Projectmanagement, Product & Procesontwikkeling, Reliability, Data Science en MedTech. We bieden zowel open inschrijving als incompany trainingen; op maat gemaakt om volledig  aan de behoeften en de strategie van uw organisatie te voldoen. Het koppelen van deze trainingen aan praktijkervaring is belangrijk om de effectiviteit te maximaliseren. Waar mogelijk worden uw eigen cases/data besproken tijdens onze training en/of verder verkend door coaching on the job, projectparticipatie en ook in de User Groups.

Bekijk ons complete trainingsaanbod in de Holland Innovative Academy