From concept to clearance…

We lead, support, or supplement your product development effort at all stages of the product lifecycle— we integrate seamlessly with your team to help make your products come to life.

Contract Manufacturing

Tailored for startups and growth-stage companies, our contract manufacturing expertise spans from verification & pilot builds to large-scale production, offering seamless scalability and dedicated support for every step.

State-of-the-art Finished Goods Assembly Facilities

  • Class 7 clean room assembly environment

  • ISO 13485 compliant facility and Quality System

  • 3rd party sterilization management

  • Strategic supply chain management

  • Fast, flexible, and specialized for startup and growth-stage companies

Single Use / Sterile Devices

Electromechanical Devices

Durable Equipment

Implantable Devices

Seamless integration drives success.

Our manufacturing team collaborates closely with our design and engineering teams during product development. By integrating production considerations early in the design process, we achieve higher quality products and expedite the transition to manufacturing. Once in production, our engineering team remains available for ongoing product support and enhancements.

FREQUENTLY ASKED QUESTIONS

  • Quality is our top priority. We employ rigorous quality control measures, including ISO 13485 standards, in-line inspections, process validation, and final quality checks, to ensure every product meets the highest standards.

  • Absolutely. Our facilities are equipped to manage both small-scale pilot runs and large-volume production runs, ensuring scalability and flexibility for our clients. Whether you need qty. 1 or qty 10,000, we can meet your needs.

  • Our agile manufacturing process allows for flexibility in design changes and order volumes, ensuring that we can quickly adapt to your needs while minimizing disruptions.