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.
Verify the clinical safety and performance of your medical
device through clinical data analysis. Clinical evaluation is based on existing literature and clinical studies.
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.
Regulatory and clinical affairs play an important role in medical devices gaining market access. Which market is easier to access with the data you have available? What about timelines and label requirements? How do we ensure speedy access to other markets? Will your clinical data be accepted? Who owns your certification? All of these questions can be answered with Qserve.
We offer regulatory support for both large, -experienced medical device companies and small, innovative high-tech start-ups. Our customized service fits your specific needs.
Qserve will meet all challenges surrounding Notified Bodies, the CAPA system, resources for global registration, maintenance of technical files, and preparation of clinical evaluation reports.
Qserve is your partner for all potential regulatory issues. We will assist with all compliance matters, from
strategy to market approval.
We offer solutions to lacking resources, hands-on expertise
for further product development, and networks for compliance with