Reduce Cost. Accelerate Scalability.

We help companies design and manufacture the most innovative FDA compliant medical devices in the world.

Personalized Time To Market Services™

transparent cost modeling
Cost Modeling
collaborative co-builds
Collaborative Co-Builds
work instruction creation and refinement
Work Instruction Creation
focused approach to dfm modularity
DFM & Modularity Focus
collaborative supply chain optimization
Supply Chain Optimization
commitment to infinite capacity
Commitment to Infinite Capacity™

Your Technology. Our Proven Process.

Expert in the commercialization of FDA-compliant medical devices and consumables in the diagnostic, surgical, dental, ophthalmic, aesthetic, rehabilitative, blood management, and imaging markets.

Much More Than a “Contract Manufacturer”

Specialized Services

The Most Advanced Capabilities Imaginable

We are dedicated to providing the highest quality services, with a specialty niche in laser and optically based technologies, consumables and FDA compliant medical device commercialization.

  • Design Compliant to 21 CFR 820.30
  • Expertise in Optics & Class 4 Lasers
  • Surgical Fiber & Sterile Consumables
  • Certified Class 7 Clean Room

Strategically Integrated

Vertically Integrated, Where it Matters

In-house printed circuit board assembly (PCBA) ensures quality and control over a critical piece of the manufacturing process, accelerating time-to-market and eliminating delays and margin stack.

  • Design and Layout Services
  • 24/7 High Speed Line Availability
  • AOI, Flying Probe, In-Circuit Test, 3D X-Ray
  • Lot 4 Traceability & Silicon Expert™

Scaled Product Launch™

Our Proprietary SPL™ Process

A well-documented phase gate approach to successful new product introduction that focuses on speed, cost reduction, second sourcing, and build efficiency with intense collaboration.

  • Elimination of Tribal Knowledge
  • Documentation Verification & Validation
  • Serialization & Traceability Assessment

Infinite Capacity™

Never Miss a Market Opportunity™

Our commitment to providing the resources, facilities and equipment to handle unthinkable and unpredictable market demand, enabling you to say YES to every market opportunity.

  • 24/7 Production Availability
  • Finished Goods Storage & Distribution
  • Aftermarket & Refurbishment Services

Compliance & Certifications

Process and Results that Meet or Exceed All Expectations

Commercialize products compliantly with all applicable standards, statutory, and regulatory requirements. We have unmatched experience working with a range of regulatory agencies including CSA, CE, TUV, and IEC.

ISO 13485:2016

ISO 13485:2016


UL Certification

IPC certified

IPC 610, 620, J-STD-001

rohs compliant

RoHS Compliant


ITAR Registered

At the end of the day, what we really build is TRUST.

medical device manufacturing

Reduce Cost.

Accelerate Scalability.