Clinical and Regulatory Services for Medical Devices

Medical Device & Diagnostics Regulatory Affairs

  • Regulatory strategy development and pathways to market
  • Consultancy services and support throughout the product life cycle
  • Device classification determination, intended use statement development and predicate device determination
  • Pre-market, post-approval and post-market support
  • Appraisal and evaluation of technical documentation
  • Preliminary assessments, gap analyses and desktop audits
  • Technical files, design dossiers and quality system support
  • European authorized representation services and UK responsible person services
  • Notified Body discussions and pre-submission FDA meetings