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Registration Support

ClinChoice leverages its team of regulatory strategists and in-country affiliates for first-time-right product registration and maintenance submissions to health authorities.

  • Complete Registration Support Services

    • Preparation of regulatory documentation and submissions for product registrations and listings in country-specific formats
    • Expertise preparing:
      • Pre-submission support documents
      • 510(k) premarket notifications
      • Investigational device exemption applications
      • Premarket approval applications (PMA)
      • 513(g) requests for classification
      • De Novo classification applications
    • Submission of regulatory documentation and applications through health authority portals
    • Assessment of design history file (DHF) and review of clinical, safety, and risk documents
    • Support for registration of local and foreign establishments in new markets before product registration
    • Comprehensive support for ISO 13485 certification to aid product registration in specific markets
    • Authoring of standard operating procedures and detailed work instructions to accelerate the creation of regulatory documents and submissions for different countries
    • Organization of documents for product registration in the QMS to reduce authoring time and shorter response time to health authority queries
    • Support for creation of legal documents for import and export based on country-specific requirements
    • Preparation of new or upgrading of existing clinical evaluation and technical documents