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Early Concept Design & Feasibility

Engineering for the End-Game.

Early Concept Design & Feasibility

We bridge the gap between napkin sketches and manufacturable reality. Our engineers utilize Design for Manufacturability (DFM) principles from Day One, ensuring your prototype isn’t just functional—it’s scalable. We don’t just design products; we design the path to market, minimizing costly late-stage engineering changes that sink startups.

What We Offer?

Concept Feasibility & IP Strategy:
We evaluate the technical viability of your device while ensuring your intellectual property is defensible and unique.
Rapid Prototyping (Functional Models)
Iterate faster with high-fidelity models that allow for immediate tactile feedback and benchtop testing.
Design History File (DHF) Remediation
We organize and backfill critical documentation to ensure your design evolution meets every regulatory requirement.
DFM / DFA Optimization
Iterate faster with high-fidelity models that allow for immediate tactile feedback and benchtop testing.
Engineering the user interface to reduce use-error and comply with IEC 62366-1 standards.
We evaluate the technical viability of your device while ensuring your intellectual property is defensible and unique.

Have a project in mind?

Early Concept Design & Development
Regulatory Strategy
QMS Implementation
Project Development & Precision Manufacturing
Supply Chain & Logistics

Get a free consultation?

Our Head Regulatory Consultant

Kelsey Lee

Over 16 Years working with the FDA : You don't want your dream in anyone else's hands.

First-Time Clearance

Strategic submissions that eliminate AI requests

Scalable QMS Architecture

Built for startups, ready for enterprise

Cutting Edge Design without the Stress

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Our approach is straightforward— We engineer bold, defensible regulatory strategies that push your device through the FDA and into the field.

WANT IT TO SOUND PLAYFUL, LUXURIOUS, OR MORE/