Medical Devices

  • Classification of your MD / AiMD / IVD device according to current MDD, AIMDD or IVDD and new MDR or IVDR
  • Technical File or/and Design Dossier submission under the current MDD, AIMD or IVDD
  • 510(k) clearance and PMA approval (US)
  • Regulatory approval strategy for your device (EU & US)
  • Selection of reference product or/and predicate device
  • Interpretation and implementation of new MDR & IVDR
  • Identification of the right Notified Body for your device
  • Interactions with Notified Body and other authorities
  • Lifecycle of medical device / conformity assessment
  • Post Market Surveillance
  • ISO 13485 Quality Management System compliance
  • UDI / Serialization setup
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