The regulatory one-stop-shop for medical device compliance
Working with a global team of experts, Qserve manages a diverse array of projects in the medical device industry. Together, we bring your medical device to the global market, complying with international regulations and assuring product quality and safety.
Regulations vary depending on the medical device and market you wish to enter. Our teams offer support for all regulatory compliance issues worldwide.
Experience a practical approach based on your existing regulatory data. Our team supports medical writing of clinical evaluations (MEDDEV 2.7.1.), as well as full-service CRO activities.
Health authorities determine market approval based on
different dossier formats and requirements. With our global network Qserve covers
a large percentage of these markets around the world.
Implement and maintain a Quality Management System (QMS) to ensure your medical device meets certain specifications and requirements.
In-house knowledge of regulatory and quality requirements facilitates the product-to-market process and provides insight into clinical safety and
Audits are executed to determine regulatory
compliance and improve the affectivity of your internal processes and those of your subcontractors and suppliers.