EU MDR Technical Documentation / Gap Analysis/ Submissions
Our experts review device design, risk analysis, clinical evaluation, testing reports, post-market surveillance, labeling, and other required areas. Gap analysis is carried out to ease the transition in the required areas. To meet with the New EU Medical Device Regulation (MDR) in which safety, efficacy, and performance measures are required in technical documentation, many manufacturers with CE Certification under MDD need to convert their documentation to meet the new Medical Device Regulation (MDR). The existing files shall be reviewed and upgraded with quality materials to meet all requirements. The Clinical Documentation process begins with a clearly designed Evaluation Plan which, entails the methodological and systematic approach to reach adequate reporting. It provides a step-by-step approach to conducting and documenting each procedure. In the MDR, Chapter VI, Article 61 the critical issues to be considered for clinical data with regards to general safety and performance are discussed. Our experts have developed forms and templates that can be customized for mandatory procedures of the Clinical Evaluation Record.