At this stage you have now completed all the regulatory requirements for device and the technical file is now signed off by your Notified Body.

During this phase we can support on the following:

  • Updating Risk Management
  • Update regulatory strategy
  • Setting up post market clinical studies
  • Ethics approval for Post market clinical studies
  • Regular updates to the Clinical Evaluation report (Meddev 2.7.1 Rev 4)
  • Quality Audits
  • Update re-imbursement strategy
  • Writing clinical protocol for Post market clinical study
  • Setting up EDC (Electronic Data Capture) for studies
  • Biostatistics
  • Preparation and adaptation of informed consent
  • Site selection
  • Site Initiation visits, interim monitoring visits and close down visits
  • DSMB and CEC
  • Safety reporting
  • Final report

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