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We can design and develop your next breakthrough idea from concept to finished product.
Product Design & Development
We can develop custom fixtures and electronic boards for specific or standardized testing protocols for your product or process.
Custom Mechanical and
Electrical Testing
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We can do prototype runs or small batch productions to verify the integrity and consistency of your product performance.
3D Printing & Small Batch Production
We can engineer and develop your idea to your specifications and verify its performance.
Project Feasibility Studies
As part of the Design Controls aspect of developing any medical device, we can verify and validate your next medical breakthrough through rigorous and standardized testing protocols.
Verification and Validation Services
We can design and manufacture and assemble your circuit board electronics and embed custom software.
Electronics Design and Assembly
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We can help you streamline the path towards Intellectual Property submission with documentation and artwork.
Intellectual Property Documentation
As part of any medical device development, we will help you with any regulatory submission to the FDA (510k), or CE-Mark (Europe).
Regulatory Submission
(510k, CE Mark)
With our ISO 13485 certified Quality Management System, we comply with FDA 21 CFR Part 820 Good Manufacturing Practices.
GMP Manufacturing & Assembly
(ISO 13485)
