At this stage you have locked the design of your device and are now focusing on validation and verification to proof it can meet the safety and performance claims in your technical file.

During this phase we can support on the following:

  • Design history file
  • Risk Management completed
  • Update regulatory strategy
  • Validation
  • Clinical Evaluation report (Meddev 2.7.1
  • Rev 4) updated and completed
  • Usability testing/Human
  • Factors
  • Update re-imbursement strategy
  • Early phase clinical studies
  • Regulatory approval and Ethics Approval for clinical studies
  • Site selection and assessment
  • Update QMS system
  • Finalise packaging and labelling
  • Finalise Instruction for Use (IFU)
  • Electrical safety
  • Biocompatibility and
  • Biological Risk
  • Assessment
  • Post market clinical follow up Plan