From concept to scale with clarity and compliance.
Arrotek accelerates medtech development for startups and OEMs, delivering regulatory confidence and global scale.
From concept to scale with clarity and compliance.
Arrotek accelerates medtech development for startups and OEMs, delivering regulatory confidence and global scale.
Making your medical device a success, without the guesswork
Our process connects design, engineering, regulatory expertise, and manufacturing into one accountable pathway — helping medtech teams move faster with less risk.
Tailored to your journey
Startups
Turn your concept into a manufacturable prototype with clarity and speed. We give startups structured momentum and regulatory confidence from day one.
OEMs
Unblock projects and scale faster with an embedded partner you can trust. We provide OEMs with external capacity, compliance, and global scalability.
Your first step:
The Prototype Sprint
The Prototype Sprint is a structured, fixed-scope engagement that delivers a manufacturable prototype and regulatory clarity in 90 to 180 days. It is the fastest and safest way to build momentum for your project.
Requirement
Define User Requirements
Concept
Group Ideation
Development
Select Designs
1st Prototype
Produce Physical
Models
Refinement
Select One Design
2nd Prototype
Based On Refined Design
Global capability, proven in Costa Rica
Our Costa Rica facility combines FDA-grade quality with cost-efficient scalability, giving OEMs confidence to move from prototype into full production.
The strengths behind every project
Speed with Structure
From concept to prototype in 90 to 180 days, with clarity at every step.
Integrated Model
Design, engineering, and regulatory aligned in one accountable partner.
Regulatory Built-In
Compliance from day one, no costly rework later.
Global Execution
Future-proofed for scale with Ireland, Boston, and Costa Rica capacity.
Proven outcomes in medtech innovation
"Whether its in manufacturing, development, or regulatory - we've achieved stellar results."
Dr. Habib Frost
CEO, Neurescue
Start your project with confidence
Whether you are a startup or an OEM, Arrotek is ready to help you accelerate development with clarity and compliance built in from day one
