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Regulatory Compliance

ClinChoice specialists leverage in-house regulatory intelligence and strategy teams to establish processes and checks for compliance with mature and emerging market regulations.

  • Regulatory Gap Analysis
  • Device suitability for therapeutic use; certification and re-certification of medical devices (CE marking, labeling, conformity assessments, import approvals)
  • Presence of Systems for Compliance – Quality management system – QMS (gap analysis and implementation), Post-market surveillance system, Clinical evaluation and post-market clinical follow-up (PMCF) system, Vigilance system, Risk management system
  • Labeling and unique device identification (UDI) implementation and maintenance
  • EUDAMED submissions
  • Economic Operator (EO) assessment
  • Importer, distributor compliance
  • Assessment of Design History Files

 

Processes and People

  • Clinical evaluation process
  • Technical document and GSPR prep that meet EU MDR regulations based on device risk class
  • Toxicologists to support biocompatibility risk assessment
  • Human factor engineers to support usability studies