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Regulatory Strategy

ClinChoice strategists help medical device innovators enter new markets and maintain their registration statuses in existing markets with a deep understanding of complex regulations, knowledge of product-specific nuances, and engagement with health authorities.

  • Comprehensive Regulatory Strategy Solutions

    • Strategy setup from the start of product development
    • Market selection for first-launch based on regulatory complexity
    • Recommendations for implementation of best practices that can be replicated to accelerate product registration in other markets
    • Level of evidence needed based on the target market
    • Competitive landscape and target market assessments to identify reasons for successes or complications
    • Gap identification and providing a regulatory pathway to meet global or local product registration and maintenance requirements
    • Documentation reviews for new and existing products including but not limited to:
      • Device classification
      • Predicate device
      • Performance tests
      • Pre-clinical data
      • Clinical evidence
      • Labeling claims
      • Supporting literature
      • Intended uses and clinical applications
    • Evaluate existing technical files, design dossiers, clinical evidence (CERs), and quality management systems (QMS) to ascertain compliance with EU MDR and develop remedial plans as needed