Regulatory Affairs & Quality Assurance, EU MDR Lead
Consultant, EU MDR Lead
At Qserve, Robert has worked for several customers as Quality and Regulatory Officer, supporting them with and/or creating Clinical Evaluations, Quality Management System remediation projects, CAPA management, risk management, postmarket surveillance plans, responding to Notified Bodies on any non-conformities found during audits, conducting and supporting audits, training on ISO13485, MDSAP and MDR.
As Robert speaks English, German and Dutch fluently he works for German, Dutch and international customers on a regular basis.
The key expertise areas of Robert
- Technical knowledge about biomedical signal analysis, biomechanics and human anatomy of the motor system.
- Building, upgrading and remediation of QMS systems
- Clinical evaluations
- Internal audits
- Supporting Notified Body audits and responses
- CAPA management
- Training
- Risk Management
- Medical devices:
- Dental products (abutments and endodontic sealers)
- Optics (rigid contact lenses)
- Radiopharmaceutical injector
- Woundcare products
- Nasogastrical feeding tubes
- Prosthetic devices
Robert about working at Qserve
“I always knew as student I wanted to get in to consultancy. I found my main interest in Medical Devices. When the CEO of Qserve, Jan van Lochem, spoke on the Alumni day at the university, I knew I found the right match. Regulatory was completely new for me when I started. But that didn’t stop me from taking the amazing challenge I got offered to work in Regulatory Affairs. So far, with all the training from Qserve, I have found my way in the Qserve team as Junior Regulatory Affairs Consultant. And I’m really excited for what the future will bring me at Qserve.”
Before Qserve
Robert Paassen has a Master’s degree in Biomedical Engineering from the University of Twente with a specialization in neural and motor systems and focus on signal analysis and with some applications in machine learning.
During his Master’s thesis he developed a beginning step detection and prediction algorithm for lower limb myo-prosthesis at a Rehabilitation Technology Institute. Besides studying, he also did organizational work for soft skills.