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.

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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 Medical Device Software 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 Medical Device Software training you will learn:

  • Quality Management System based on ISO 13485 for a software company
  • 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 course One Day Training Medical Device Software 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 One Day Training Medical Device Software 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: Enschede
March 11

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.

Teachers

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 One Day Training Medical Device Software 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

Training advice?

Would you like to receive more information about this course? Our program managers can tell you more about it! You can reach them from Monday till Friday from 08:30 till 17:00.

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

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About the Holland Innovative Academy

Holland Innovative helps to develop the competencies of you and your colleagues to strengthen your organization and create growth. Together with renowned centres of expertise such as Eindhoven University of Technology, Twente University, Delft University of Technology and the University of Stuttgart we organize courses, trainings and masterclasses in Project Management, Product & Process Development, Reliability, Data Science and MedTech. We offer both open enrolment and in-company training; tailor-made to fully meet the needs and the strategy of your organization. Coupling these courses with practical experience is important in order to maximise the effectiveness. Where possible, your own cases/data are discussed during our training and/or further explored by coaching on-the-job, project participation and also in the User Groups.

Check the complete training program of the Holland Innovative Academy