Medical Device Support

Medical Device Support

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The postponed MDR comes into effect in May 2021 and to ensure the continued compliance of your medical device products to the new legislation we have a comprehensive suite of services. Whether it is determining the status of your QMS and related processes to ensure that manufacturing, development, and related control facilities meet the applicable standards our experts or support in the writing of your Technical File, our experts can join your team at any point and time. Activities in this area that you might be interested in: - Risk Classification - Conformity Assessment Procedure - Implementation Plan for MDR / IVDR - Product Documentation - Quality Management System services

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