Requalite is a medical device Regulatory Affairs and Clinical Study services company located at the heart of Europe, in Munich-Germany. We provide full CRO services for Clinical Studies and technical support to manufacturers of medical devices in accordance with EU regulations of MDR and IVDR. We consult manufacturers of in vitro diagnostic and medical devices on the planning, preparation, execution, and reporting of all required technical documentation for existing as well as novel devices to obtain CE-marking.
Requalite, Regulatory and Clinical Study services for medical Device Compliance in Europe.
Requalite facilitates the medical device conformity process by providing an extensive and bespoke portfolio of services for healthcare companies in their compliance journey. We meticulously help prepare our clients for their Audits and submissions with the notified bodies and competent authorities in accordance with European regulations.
Requalite offers a customised and flexible menu of solutions for its clients need in compliance process. We administer amendable solutions for your requirements, whether you are in search of one-time individual project, or looking for a long-term support. We modify our solutions as per the clients capacity and resources to address regulatory and clinical services.