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Technical Document Submission & Approval Preparation

ClinChoice’s experienced teams lead complex dossiers and technical file development using the latest regulatory intelligence and industry-leading best practices.

  • End-to-End Technical Document Support

    • Collation and organization of data for technical documentation, GSPR, and clinical evaluation
    • Authoring of technical documentation and GSPR in alignment with EU MDR and global regulations
    • Toxicologist support with biocompatibility risk assessments
    • Human-factor engineer support with usability studies
    • Information reviews related to the design, function, performance, composition, use, claims, and clinical evaluations and ensure compliance with regulatory requirements
    • Review of dossier structures per the regulations of different countries and regions
    • Gap analysis to identify documentation deficiencies, including those related to:
      • Device identification
      • Description
      • Intended use
      • Labeling
      • Manufacturing information
      • Risk management files
      • Post-marketing surveillance
      • Verification and validation of the device
    • Review of clinical data and compilation of the Clinical Evaluation Report (CER)
    • Development and assessment of risk management files, product specifications including labels, and Instructions for Use
    • Compilation of documentation and specifications required for medical device manufacturing