- Develop your clinical strategy for the European market
- Implement and drive your clinical research in Europe
- Obtain CE Mark for your device
- Be compliant with the regulatory requirements
- Manage the process with notified bodies
- Launch your device in Europe
- Make a Go/No Go decision
- Understand or implement a European reimbursement strategy
- Define and execute a training and professional education strategy
- Identify and set up centers of excellence fitting your goals
- Create a highly skilled management team
- Use full-time/part-time interim employee, or with a transitional leadership
- Finance your development with equity investment
- Obtain legal opinions
- Organize specific events in Europe
- Get physician's feedback on your technology
- Publish in peer review journals
- Build your business plan / Marketing plan
- Set up your European operations