Working with a global team of experts, Qserve manages a diverse array of projects in the medical device and IVD industry. Together, we bring your medical device to the global market. Do you need a partner to support you with getting your product ready for Market Approval? We offer a wide range of compliance services including, regulatory strategy, device registration, quality management system compliance, and in-country regulatory representation.
Regulatory consulting for device and IVD companies
The registration process of a medical device starts with classifying. Your device class determines the regulatory route to compliance, including the required documentation, clinical data and safety requirements, and more.
Regulations vary depending on the medical device and market you wish to enter. Our teams support you with global challenges in Regulatory Affairs and Quality Assurance worldwide
Clinical Evaluation (CER) or Clinical Studies
Clinical Evaluation Reports are required for all medical devices in Europe. You must submit your CER to your Notified Body as an attachment to your European CE Technical File. We support all of your Clinical Evaluation Reports, pre-CE clinical studies and Post-Market Clinical Follow-up (PMCF) challenges. Together we will secure sufficient clinical evidence to satisfy the regulator.
ISO 13485 - QMS for Medical Devices
Medical device regulators in most markets require device companies to maintain a quality management system to obtain device approvals and registrations. Some markets recognize certification to international standards like ISO 13485, other markets require compliance with a local quality management regulation. e develop, implement, and maintain quality management systems that comply with QMS requirements in all medical device markets.
Regulatory, Quality and Clinical Training
Qserve offers medical device manufacturers training at all regulatory, quality, and clinical levels. Qserve's staff offers years of international experience with both broad and specific expertise for a wide range of medical devices and IVD's.