We help you choose the right route early, so the submission is planned rather than rushed.

What we do

• Choose the regulatory pathway for each target market
• Build the submission team with experienced regulatory consultants
• Coordinate FDA 510(k) and EU MDR submissions
• Arrange Free Sale Certificates and country registrations
• Keep everything in one master regulatory file

Why it matters

With one master regulatory file, each new country becomes a gap analysis rather than a new project.

If your device is already FDA cleared, we start with the markets that accept that clearance, so sales can begin sooner.

We work with highly experienced regulatory people, and when needed we outsource to leading companies in the field.

Our team has taken devices from R&D through FDA clearance to launch.

Who it’s for

Medtech companies planning their first submission, or with a cleared device that they want to register in more countries.

Tell us about your device and your target markets, and we will map the regulatory route with you.