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EMS Capital Equipment
NextPhase Medical Devices

EMS Capital Equipment Manufacturing

A trusted medical device contract manufacturing partner for your Class I, II, and III electronic EMS Capital Equipment

Looking for a turnkey, U.S.-based, and FDA-compliant EMS Capital Equipment medical device manufacturer for your entire product life-cycle?  We have a proven trackrecord of reducing manufacturing costs by expediting production timelines while holding to the highest standards of quality. Our robust quality systems have earned a strong reputation with some of the largest names in the medical device industry. We understand the unique standards and requirements of all Class I, II, and III medical devices.

As a customer, you can count on best-in-class services, well-planned processes, attention to all details, a do it right the first-time approach, and a dedicated, responsive team that leverages our buying power, oversees manufacturing execution systems (MES), and maintains all medical device history records.

We reduce a product’s time to market and maintain full compliance in accordance with regulatory requirements, thus allowing our customers to focus on their core business.

Product applications

  • Arthroscopy and orthopedic surgery support systems
  • Battery-powered devices and battery charging
  • Cryotherapy devices
  • Dermatology systems
  • Diagnostic carts
  • Doppler ultrasound devices
  • Electronic tissue ablation devices (RF)
  • Electrosurgical systems
  • Endoscopic light sources (xenon, metal halide, fiber optic, UV)
  • Endoscopy devices
  • Fluid management/fluid monitoring systems
  • Hydrothermal ablation systems
  • Laparoscopic/hysteroscopic insufflators
  • Neurological diagnostic devices
  • Tissue ablation devices (RF, Cryo)
  • Vision testing systems
  • Wireless systems data transfer and integration (WiFi/Bluetooth)
 

Product design and development

  • Software architecture
  • Requirements document
  • Design and product validation
  • Device History File or Device Master Record
  • Electrical layout and overall wiring design
  • Electronic Design
  • Industrial Design, concept development, voice of customer (“VOC”) research
  • Mechanical Design, 3D computer-aided design (“CAD”) SolidWorks
  • Packaging design and ISTA approval
  • Printed circuit board design
  • Prototype and clinical evaluation support
  • Software/firmware development
  • User interface design and graphical user interface (“GUI”)
 

Do you have a question for our EMS capital equipment team?