Medical Device Assembly Companies

Full-service contract manufacturing partner

NextPhase provides comprehensive, integrated contract manufacturing services for finished Class II and III therapeutic and diagnostic medical devices. We have the manufacturing capabilities to ensure quality, speed, and a smooth transition into the marketplace.

Our team can partner with you to turn your concepts into reality in our four manufacturing facilities in North America:

  • ISO 13485:2016 certified
  • FDA registered
  • cGMP compliant
  • ISO Class 7 & 8 clean rooms
  • Model & prototype assembly labs
  • Manufacturing scalability

LEAN manufacturing culture

At NextPhase, LEAN is more than a process—it’s baked into our culture. We use LEAN philosophies, tools, and systems to maintain an environment of continuous improvement. Our goal is to continuously improve the quality of your medical device while reducing cost.

Comprehensive manufacturing capabilities

NextPhase partners with medical device market leaders to design, manufacture, assemble, and package single-use devices and electromechanical devices (EMD).

Our manufacturing capabilities include:

Clean room assembly
  • ISO Class 7 & Class 8 certified clean rooms
  • Complex disposable devices
  • Metal and plastic joining, including welding and bonding
  • In process and post assembly device testing
  • Sterile and non-sterile packaging
Electromechanical assembly
  • Design for Manufacturing (DFM)
  • Supply-Chain Management
  • Process Validation / Gage R&R
  • Assembly
  • Packaging and Distribution
  • Capability to Test and Burn-in
  • Full traceability – Lot and Serial numbers
  • ESD Controlled
  • Post-Production Support
Materials joining
  • Laser beam welding
  • Resistance welding
  • Tungsten inert gas (TIG) welding
  • Ultrasonic welding
  • Adhesive bonding
  • RF welding
Performance testing
  • Leak and Flow
  • Pressure
  • Continuity
  • Hi-Pot
  • Burn In Test
  • RFID Read/Write
  • Tensile/Peel
  • Accelerated Age
  • Real Time Age
  • ISTA Transit
  • Biocompatibility
  • Ethylene Oxide and Gamma Sterilization Validation

Ready to talk about your complex medical device manufacturing project?