About us

You are in safe hands.

We believe the complexity of medical device certification shouldn’t hold you back. Every medical device company—whether a small startup or an industry giant—deserves a clear path to regulatory approval without unnecessary delays, confusion, or excessive costs.

We understand how challenging the certification process can be for your team and how critical securing regulatory approval is for your success.

Every day, we empower innovators like you to navigate the certification process. With over 20 successful approvals, we can significantly streamline your path to market.

What you’ll gain:

  • Team clarity throughout the certification journey: Always know where you stand in the process.
  • Cost savings through automation: Eliminate tedious, repetitive, and error-prone tasks.
  • Hassle-free compliance: Achieve certification smoothly with a compliant device.

How you’ll feel:

  • Relieved: The certification process is expertly managed.
  • Confident: Rest assured you’re not missing any steps.
  • Accomplished: Take pride in launching your device.

What makes our service unique:

Complete visibility of the certification journey: Know exactly where you are at every step.

Transparent pricing from the start: No variable fees—understand your expenses upfront.

Modern software platform: Certification tools that are up-to-date and user-friendly.

High-quality templates: Designed to meet MDR, FDA, and other regions’ requirements.

Expert guidance: Backed by extensive experience from certifying 20+ medical devices.