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"In reality, not everything is black and white"

What is needed to put a medical device on the market?

How to conduct good clinical research?

Which parties are involved?

A small selection of questions that may arise when you deal with medical devices.

With a good dose of common sense, you can turn legislation and regulations into an effective process that works in practice.

That is exactly where I come in!

READ MORE ABOUT ME

Rianne Tooten in 2 minutes

The world of medical devices can be complicated if it is not 100% clear which path you should take.

With more than 10 years’ experience in clinical research with medical devices, as a clinical research consultant, I am happy to help professionals find the right path for them.

The trainings and tailor-made support I provide, help professionals to find their direction. It is my mission to transfer my knowledge and experience as much as possible, by translating legislation and regulations into practice. All the services I offer are therefore personal, practical, and directly applicable.

Where customization is needed, we can work together to investigate the issues that apply to you.

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TRAINING

For the practical implementation of legislation and regulations in practice

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ADVICE

To help you get customized answers to specific questions in your daily practice

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SUPPORT

For intensive support and guidance in the implementation process

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Free Q&A session?

For a short substantive question, I offer a free 15-minute consultation.

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Contact

Are you curious to see where I can help? Fill in the form below and I will get back to you as soon as possible.

Clients say

“Very well organized training, lots of up to date knowledge and communicated in a good clear way”

Marieke van der AFreelance Clinical trial monitor, CRA, research professional

“Rianne conveys a deeper knowledge and awareness of clinical trial guidelines and helps you get prepared for the new MDR regulation”

Titia GussinkloResearch Coordinator, datamanager at Erasmus MC

“Rianne is an expert in the field of Medical Devices and shares her knowledge regarding the MDR in a calm way. She is dedicated to her goal to spread the awareness“

Evelyn Suttorp-SchmitzFreelance Clinical Research Professional at PtrialS

“Rianne has given me a very nice overview of what is involved in the world of medical devices and what the current state of affairs is in the Netherlands (and the rest of the world).”

Irma ScheepstraOwner Scheepstra Clinical Research Services

”What a great training! It was set up that all could be followed with even limited or no medical device experience. A nice extention and refresher on my broad clinical knowledge. There was plenty of time for some nice discussions“

Femke OvermarsFreelance CTM, srCRA at OCTS

”In addition to being a thoroughly nice individual and very knowledgeable in device clinical development, Rianne has an outstanding ability to very quickly familiarise herself with a project and integrate herself into a team which is invaluable for a virtual company. Rianne consistently went above and beyond what was expected of her and made a huge personal contribution to the project. I personally learnt a lot from working with Rianne on our project“

Neil McDonald, PhD MTOPRARegulatory Affairs Manager at Edinburgh Molecular Imaging

”The training was very inspiring. Enough room for discussions and questions in a small group. I had a great day!“

Margot GerritsFreelance Clinical Research Professional at CooData

“Rianne is a great trainer who can clearly convey essential elements in a short time.”

Susan HommersonCoordinator medical & medical device research at Eindhoven University of Technology
The training was extremely valuable for me, since I'm applying for investigation approval as a PI. The training helped me a very great deal in preparing the application material, planning the investigation and organizing all processes involved. I was afraid that the material would be very confusing and rather boring, but Rianne made the information digestable and even interesting. Even after I passed the test, I have watched all the videos at least another 2 times, and it has been a great help during investigation planning. I absolutely recommend this training!
Prof. dr. Gutierrez FarewikKTH Royal Institute of Technology
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