21 December 2023 - Medical Device Software: Shaping the Future of Clinical Research and Healthcare

Webinar Topic

Medical Device Software: Shaping the Future of Clinical Research and Healthcare


Webinar Date & Time

21st December from 10:00 AM to 11:30 AM (CET)

Webinar Overview

Software is becoming increasingly common in healthcare and clinical research. Therefore, it is good to know whether you are dealing with Medical Device Software (MDSW) and with the Medical Device Regulation (MDR). Not only MDSW manufacturers are confronted with the MDR, but also the pharmaceutical and food industries, not to mention researchers and healthcare providers.
MDSW can be used, among other things, to monitor patients for diagnostic or therapeutic purposes. MDSW is used in clinical research in many ways. Not only for validation of the safety and performance of the MDSW, but also as a “tool” to collect patient data, monitor vital functions, provide (therapeutic) instructions and measure compliance. Ideal in a decentralized clinical research setting, which will increasingly be the trend in the future.
But when is software considered a medical device? And which risk classification applies? What are the manufacturer's obligations for these specific risk classifications? And how does this impact the decision to set up a clinical investigation?
In this webinar, these questions will be addressed using several practical examples.
The webinar will be concluded with a 30 minutes Q&A to give you the opportunity to ask all your questions, to comment and/or share useful insights.



Rianne Tooten


Rianne Tooten - Clinical Trial Services 

Rianne Tooten holds a Bachelor of Science in Medical Biology. She currently has more than 15 years of experience in medical device clinical research. From pre- to post-market studies and from medium to high-risk medical devices.

Rianne Tooten is the founder of “Rianne Tooten – clinical trial services”, a training and consultancy agency dedicated to supporting clinical research with medical devices and new medical technologies. She is a Medical Device Expert of the Medical Research Ethics Committee of the University Medical Center Groningen and is a member of the NVFG, ACRON and has an active role in the Medical Device working group of the EUCROF.

Her mission is to transfer her knowledge and experience to help clinical research professionals find practical solutions for the interpretation and implementation of the MDR and ISO14155, the GCP for clinical research of medical devices, by translating them into their daily practice.


Attendance Fee

€ 90,- for non-EUCROF members

€ 60,- for EUCROF members

Deadline for registration

20 December 2023 at 6 p.m.

How to register?

1) Go on the REGISTRATION PAGE and click on the red button "RESERVE A SPOT"

2) Check your order and click on the green "CHECKOUT" button

3) Fill in all the necessary information and validate your order


You will receive 2 confirmation emails:

A) One from Eventbrite with your invoice

B) One from "GoToWebinar" with all the necessary information to connect the D-Day!


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