HI-MT3 One Day Training Medical Device Software

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

Medical Device Software  - opening image

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.

Lisette van Steinvoren - Stamsnijder

Lisette van Steinvoren - Stamsnijder

Competence Lead MedTech & Sr. Project Manager Medical
Lisette is a dedicated project manager with several years of experience in innovative product development within both multinationals and SMEs. She is passionate about creating relevant products, especially when they are health and environmental related. Lisette has a background in Engineering Physics & Innovation Management. She is Black Belt and IPMA C certified.

Training information

  • Hybrid
  • 1 module of 1 day

Investment

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.

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.

Training: Medical Device Software.

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.

MTs - outcome

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.

Medical Device Software

Yes, save my seat.

We’ll email you within 1 working day with the next steps

What you’ll learn.

Day 1

What you'll learn

  • 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 are able to take the course. 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) 
 
Dates 2021 
Location: Eindhoven 
Day 1: September 23

 
Group size 

A maximum of 10 participants 

Save your seat

Get started and save your seat.

Take the next step in your personal development.