REGULATORY APPROVAL

The international regulation of the medical devices market demands an international approval strategy. Qcmed supports you in creating a tailored concept.

CE Marking

Active Implants (90/385/EEC)
Medical Devices (93/42/EEC)
In-vitro diagnostics (98/79/EC)

  • Product classification
  • Selection of the conformity assessment procedure
  • Technical documentation
  • Selection of notified body
  • Implementation and coordination of regulatory approvals
  • National registration

Risk Management

  • Risk analysis and management
  • EN ISO 14971, EN ISO 22442, IEC 80001-1
  • Risk management file
  • Post-marketing surveillance
  • Monitoring and reporting system
  • (MEDDEV, MPSV, MDR)

USA: Your way to FDA

  • Classification
  • Documentation (DMR)
  • 510(k), IDE, PMA
  • Establishment registration
  • International device listing
  • Other countries upon request (e.g. Canada, Australia)

Technical Documentation

DMR, DHF

  • Conforming to standards, ready for submission
  • In accordance with your Notified Body
  • Instructions for use, labelling
  • International strategy