At Qserve, we take pride in our team of experts who support global registrations for medical devices in various countries. Today, we are excited to introduce you to Dennis Sarwin, Team Manager of our Global Registrations department. In his role he oversees global registration strategies, coordinates cross-regional submissions and ensures alignment with diverse regulatory requirements.
Dennis joined Qserve in May 2022 as a Regulatory Affairs Associate, becoming part of the Global Registrations team. In this role he gained experience in reviewing and registering technical files for the UK Responsible Person and European Authorized Representative service, creating global market access strategies and helping organizations achieve ISO 13485 compliance.
With an educational background in Industrial Design Engineering followed with a Double Master of Science degree in Integrated Product Design (Medisign track) & Biomedical Engineering, Dennis has gained thorough knowledge. Next to his studies he had the opportunity to gain regulatory affairs experience at various medical device companies, where he learned how companies work with quality management systems (QMS) and register their products across the globe.
In his current position as Team Manager, Dennis leads Qserve’s international Global Registrations team in supporting medical device and IVD manufacturers in bringing their products to the market worldwide, helping them navigate global market access and country-specific requirements. In parallel, Dennis assists manufacturers as a consultant with EU MDR technical file compilation and maintenance, Regulatory Intelligence, post-market surveillance and quality affairs inquiries.
When asked how he stays updated with regulatory and global developments in the MedTech environment, Dennis answered:
"As team manager of the Global Registrations department at Qserve Group, staying up-to-date with regulatory and global MedTech developments is a core responsibility. We actively monitor changes through direct engagement with competent authorities, Notified Bodies, and industry associations, combined with hands-on experience across global registration projects. A key enabler is Qserve Insight, our Regulatory Intelligence platform, which consolidates up-to-date regulatory requirements, country-specific changes, and practical implementation guidance. By integrating Qserve Insight into our daily workflows, we ensure timely interpretation of regulatory updates, consistent advice to clients, and proactive anticipation of global market access risks and opportunities."
Our Global Registrations team has successfully supported numerous manufacturers in registering their devices through close collaboration with our trusted local partners. Ready to bring your device to the market? Get in touch with us today to explore how we can support your registration strategy.