Your Device Partner for Combination Product Programs

Trust EdgeOne Medical to set your product up for success with our proven path to market. As your device development team we’re here when you need us.

Your Product, Our Expertise
and Device Labs

From pharmaceutical giants to emerging biotech companies, EdgeOne Medical offers the proven experience, agility, and speed your program requires. Whether you’re navigating regulatory strategy discussions, figuring out sample size needs for testing or setting up to handle complaint investigations, our cross-functional device team co-located with our proprietary labs has you covered.

Since 2012, we’ve successfully guided clients, helping them bring combination products to market faster and more efficiently.

Large Pharma

You’ve got the scale in your device development team, but sometimes you need extra bandwidth or specialized expertise to keep things moving.

We know how to step in to support your device organization, and ensure your program hits every milestone.

Let’s keep your momentum going!

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Emerging Pharma/Biotech

Turning groundbreaking ideas into market-ready products is challenging without the right support.

We act as your dedicated development team, shouldering the responsibility to bring the device expertise you need through every stage of the drug development process.

Let’s bring your innovation to life!

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Trusted by 12 of the 20 Top Pharma Companies

125+

Clients Served

60+

Regulatory Submissions

50+

Design Verification Testing Programs

FDA+EMA

Registered Labs

Our Most Requested Services

Device Development

From concept to commercialization, we’re with you every step of the way. Our tailored strategies ensure your device is designed, developed, and delivered efficiently, meeting every milestone and compliance standard along the journey

Regulatory Strategy & Submission

Navigating regulatory hurdles can be complex—we make it simple. Our team specializes in crafting precise submission strategies, ensuring your device meets FDA, EMA, and global requirements without unnecessary delays or setbacks.

Design Verification Testing

Your device’s success depends on rigorous testing. We offer comprehensive, ISO 13485-compliant design verification testing, tailored to meet regulatory standards and ensure your product performs flawlessly under real-world conditions.

Complaint Investigation

Handling feedback from real-world patient experience during the clinical or commercialization phases requires timely analysis. Our program harnesses device expertise in partnership with your quality organization to ensure a smooth and efficient investigation process.