Rianne Tooten offers training, consultancy and guidance in the interpretation and practical implementation of the ISO14155 standard (the good clinical practice for clinical research with medical devices), the MDR (Medical Device Regulation) and regulatory strategies within The Netherlands.
Through short video’s Rianne shares with you her knowledge and answers to the frequently asked questions (FAQ’s).
Are you working in clinical research with medical devices? These video’s are a go-to for practical solutions to the grey areas of the MDR and ISO14155. Because let’s face it: “In reality not everything is black and white!”
Are you searching for online training possibilities on ISO14155, please visit the e-learning on the academy.
For more information on the what Rianne Tooten can do for you, have a look at the services provided.
What is the impact of the MDR and how do you translate it into your daily practice? You want to test your medical device for the first time in a clinical trial. Where do you start? What exactly is needed if your device is already on the market and you want to further investigate it? What are the requirements then? A small selection of questions that may arise when dealing with medical devices. The challenges lie mainly in the interpretation and implementation of the law and regulations, the so-called gray areas. With a good dose of common sense, you can turn legislation and regulations into an effective process that works in your daily practice, because let’s face it: in reality, not everything is black and white!
My name is Rianne Tooten and you may have heard of me via my posts on LinkedIn or as a speaker where I talk about laws and regulations regarding clinical research with medical devices, the MDR, the Good Clinical Practice for Medical Device studies the so-called ISO14155 and the regulatory review process in The Netherlands. Or maybe you have heard of me through your network, clients I have worked for in the past.
It is my mission to use my knowledge and experience to help clinical research professionals, in both industry and healthcare, to find the right way within clinical research with medical devices, where quality and integrity are of great importance.
Are you struggling with similar questions and do you need a practical translation of the law and regulations? Take a look at my training offer at the academy to see if there is a training that appeals to you. Do you have a specific question? Do you want to have an in-depth conversation or would you like more one-on-one contact? Please reach out to me and I can see what I can offer you or book a consultation directly via the website.
And don’t forget to follow me on LinkedIn, if not already, where I regularly share my knowledge and experiences.