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
