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            February 19, 幸运彩计划注册
            An update to Clinical Evaluation and Clinical Investigation guidance by NMPA

            In October 2019, IMDRF released three harmonized documents, Clinical Evaluation, Clinical Evidence - Key Definitions and Concepts, and Clinical Investigation were finally released. China幸运彩计划注册, as an IMDRF member and president for the cycle starting in 2018, proposed this global harmonization project for clinical evaluation.

             

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            Your MedTech Partner for Regulatory, Quality Affairs and Clinical Trials

            Qserve is the largest consultant company in the EU that is 100% focused on medical devices and In-Vitro Diagnostics. Check out our company video.

            Europe

            Our knowledge of the European Medical Device Regulation (EU-MDR) ensures that we can train and support you with an efficient regulatory strategy.

            China幸运彩计划注册

            We can help you navigate through the Chinese market by offering a wide range of customized services.

            USA

            We have supported hundreds of Medical device manufacturers with FDA submission. Qserve’s legal entity can act as US Agent and Official Correspondent.

            Why choose Qserve as your regulatory consultant?

             

            • We know exactly what should be prepared to become and stay in compliance with the regulations
            • Strong international team with technical, regulatory quality and clinical competence
            • Ex EU Notified Body, FDA, and CFDA staff
            • Full Medical Device CRO services
            • We have a team where we use multiple levels, from junior to principal. Depending on your project we are able to form a cost-effective team
            • We charge you for the work performed, no hidden costs
            • We train and we leave something behind, a regulatory compliance imprint
            • 1 contact point giving you access to a broad team with all expertise
            • Legal representation in China幸运彩计划注册, Europe and the United States

             

            Our method

            "Our mission is to support all medical device manufacturers with a practical approach, translating existing regulations to understandable requirements."
            Jan van Lochem , CEO