Robert van Boxtel graduated with a MSc title in the field of biomedical materials from the University of Twente in the Netherlands.
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 on 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) is participating.
During the last 7 years, as Principle Consultant, he is assisting medical device manufacturers with their QMS, product 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 the discussions on risk management, ISO 13485 and PMS as part of the standards development.
His expertise’s are: EU medical device regulations, ISO 13485:2003 and 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).