Rogier Nusselder

With nearly two decades of experience guiding medical device and in vitro diagnostic manufacturers through European regulatory frameworks, Rogier Nusselder is a trusted expert in compliance and quality management. As Senior Consultant Regulatory Compliance at Certification Experts, he supports clients with the compilation and review of technical documentation in line with MDR and IVDR, as well as the implementation and auditing of ISO 13485 quality management systems.

Rogier holds a BSc in Chemistry from the Institute of Life Sciences & Chemistry in Utrecht and has completed extensive specialist training, ranging from medical device software (IEC 62304) to sterilisation processes, clinical trials, and lead auditing. Over the years, he has led successful CE certification projects across a wide range of medical technologies, from decubitus mattresses and rigid endoscopes to haemostatic bandages, and lubricants.

As a Lead Auditor (ISO 13485) and regulatory compliance specialist, Rogier combines technical expertise with a pragmatic approach, ensuring that manufacturers achieve and maintain compliance while keeping safety and quality at the forefront.

LinkedIn: Rogier Nusselder | LinkedIn

Accreditations:

• BSc: Chemistry
• Lead auditor (ISO 13485:2003) (BSI)
• ISO 13485:2016