Contract Design & Development Services

Wherever you are in the development process, we have a flexible menu of service offerings tailored to meet your unique needs, whether that be supporting the full product lifecycle or one element of it. With expertise in materials, development, pilot production, and high-volume manufacturing, we can expand your team’s capacity, solve complex challenges, and identify innovative solutions, all in service of helping you bring successful products to market faster.

Medical device concept and design services

Concept & Feasibility

Our end-to-end process begins with understanding your needs and desired outputs. From there, our experts design your project and begin rapid protoyping. As quality is at the center of everything we do, the prototype goes through both benchtop and functionality testing.

Medical device development and testing services

Development, Testing, & Validation

Our team generates controlled design documents, verifies the product meets design intent, and validates processes to to ensure robust manufacturing processes that are stable, repeatable, and measurable.

Medical device regulatory (FDA) clearance services

Regulatory Clearance

We understand regulatory approval can be stressful, which is why we developed expertise to support you throughout the process. We facilitate getting to market quickly and efficiently with three options:

  • We serve as Legal Manufacturer
  • We serve as Legal Manufacturer & transfer Regulatory to you
  • We serve as Contract Manufacturer
Commercialization and manufacturing services for medical devices

Commercialization

Our global facilities produce over one million products daily, offering you an experienced partner in large-scale and efficient manufacturing transfers. Our team is here to support you through ramp up, long-term manufacturing and end of life.

market ready medical devices

 Market-Ready Products

Get to market faster with our selection of market ready, regulatory-approved guidewires and catheter platforms.

highest quality medical device services and products

 Quality Systems

Reduce your development and regulatory timelines with our full range of in-house product performance testing to support the design and development process and compilation of testing required to secure regulatory clearances and approvals. Each of our global sites carry its own ISO Certifications and four are FDA registered.

Precious metals for medical device manufacturing

 Precious Metal Management

Precious metals are a critical component for your device technologies. With over 170 years of materials science expertise, we offer full precious metal management and services from physical supply to trading, logistics, integrated solutions, and more.