Clinical Data for Low Risk Medical Devices with Robert van Boxtel

We talked a lot about how to perform a Clinical Evaluation for your medical device. But when your device has a low risk and there is not enough data to prove safety, how then it is possible to show that you have enough data to place your device on the market. Robert van Boxtel from MD Project will help us define what can be done as there is always a solution. Robert will help you with some suggestions on how you can collect data that you already have as preclinical data or will help you find some information regarding other devices. What is also interesting is to talk about clinical data with products that are not touching the patients at all. We will also clarify that. Don’t forget to download the presentation that Robert prepared about this topic.

Who is Robert van Boxtel?

Robert van Boxtel graduated in the field of biomedical materials from the University of Twente in the Netherlands (MSc).

For eight years he worked in the medical device industry in the Netherlands and USA, in different roles within R&D and manufacturing. In 2003 he started at Notified Body KEMA Quality B.V., currently known as Dekra Certification. In his job as Sr. Project Manager Certification Medical Devices, Robert van Boxtel worked around the globe to assess medical devices on safety and performance, and audit the QMS’s of medical device manufacturers.

As a result, he developed an in-depth knowledge of CE regulations and ISO 13485. In addition to that, he was responsible for international large accounts and the FDA 3rd party review program, in which KEMA (Dekra) was participating at the time. During the last 9 years, as Principal Consultant at Medical Device Project B.V. in the Netherlands, he is assisting medical device manufacturers with their QMS, technical files, and regulatory submissions.

In addition to that, he is hired by the Dutch Norm Institute (Royal NEN), as SME for teaching on ISO 13485 and MDD/MDR. Furthermore, he participates in TC210 discussions on risk management, ISO 13485 and PMS. As a result, he has 25 years of experience in the medical device industry.

His expertise’s are:

  • EU medical device regulations (MDR/IVDR)
  • ISO 13485:2016
  • Risk management (including animal tissue)
  • Clinical evaluation;
  • PMS;
  • QMS development/improvement;
  • Troubleshooting; Product-, equipment- and process validation;
  • Participating in / leading development projects;
  • Building Regulatory submission files (EU and USA);
  • Lead Auditor.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create to help people have a better understanding of the Medical Device Regulations all over the world.

He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…


Monir El Azzouzi and Robert van Boxtel on the Medical Device made Easy Podcast - Clinical Data for low risk devices

One Reply to “Clinical Data for Low Risk Medical Devices with Robert van Boxtel”

  1. Stephanie

    Struggled to understand precisely how to get clinical data. Too much was said that veered off the topic but I need basic understanding and this is focused more on old experience

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