The true extension of your business

Product Development

Define Product Requirement
Design for use and abuse
Human Factors Engineering
Design for Manufacturing
Failure Mode Analysis
Design Validation

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Quality & Regulatory

21 CFR Part 820 (QSR) Compliant
ISO 13485:2016 Certified
FDA Registered Facility
Electronic Quality Management System
Risk Management, Design Assurance, Standards Compliance, Process Control, Statistics

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New state of the art 36,000 sq.foot facility
Engineering, development and manufacturing
Certified Class 7 Clean Room
Sterile Kitting and Packaging
Low and High Volume Manufacturing
Analytical Chemistry Lab and Chemical Manufacturing
3D Rapid Prototyping

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