The planning phase is essential for determining the critical milestones for the development of your device.

During this phase we can support on the following areas:

  • Market Analysis
  • Quality Management System
  • Support selecting notified body in Europe
  • Design history file
  • Regulatory strategy
  • Reimbursement
  • Pre-clinical studies
  • Risk Management (ISO 14571)

Do you have a question?

Contact us now for a free, no-obligation consultation.