Medical and Biotechnology Design and Manufacturing

Conquering Complexity in Medical Device Contract Manufacturing

See first-hand how the Sparton Production System enables us to excel across all business capacities and drive performance excellence with medical applications that become more technologically advanced every year.

Medical and biotechnology device design and manufacturing often presents a wide range of challenges — and those challenges grow as the technology evolves. But with our proven record of developing both complex electromechanical devices and strong customer relationships, Sparton keeps pace.

A vital part of that is the Sparton Production System. Honed through years of refinements and improvements, our system is based on lean manufacturing processes and designed to be responsive and productive. The class I, II and III devices we manufacture use a mix of highly specialized technologies, including but not limited to robotics, fluidics, optics and lasers. At any given time, our manufacturing floors are filled with devices that play a critical role in saving lives. Whether it’s medical RF manufacturing, laboratory device contract manufacturing, software and product design or lab automation contract manufacturing, we ensure the right processes and designs are made every time.

Medical Device Product Lifecycle

No matter the complexity of your medical device design, software and manufacturing needs, Sparton’s team has the flexibility to serve as a reliable contract manufacturing partner at any stage of your product’s lifecycle. Our expertise includes:

Product Design Services

  • Definition and feasibility
  • Software development and verification
  • Transition to manufacturing

Software Design Services

  • New Product Launch Support
  • Standards and Regulatory Guidance Expertise
  • Sustaining Engineering Support

Manufacturing Services

  • Full-scale production
  • Supply chain
  • Operational excellence
  • Component and system-level testing

Certifications & Quality Systems

Developing complex, state-of-the-art medical devices requires meeting the highest regulatory standards and certifications. Sparton goes above and beyond to ensure its products meet the following standards:

  • FDA 21 CFR 820
  • ISO 13485:2016
  • ISO 9001:2015
  • Systems compliance with GMP/QSR
  • Wet testing for medical devices

Additional Compliance

  • RoHS and REACH
  • IEC 60601-1
  • UL, CE, ETL, TUV, CSA
  • Precision Fluidics and Microfluidics
  • Blood Separation
  • Chromatography
  • Motion Control
  • Robotic Handling and Pneumatics
  • RF Ablation
  • Optics and Lasers
  • Electrophoresis
  • Thermals
  • Live Tissue Processing
  • Oxygen Fuel Cells
  • Magnetic Stimulation
  • DNA Sequencing
  • Cell Separation and Processing

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  • Orthopedic Devices
  • Opthomalogical
  • Respiratory
  • Vital Signs Monitoring
  • Electronic Medical Records
  • Patient Information System
  • Hearing Devices
  • Intrasseous Infusion
  • Electrosurgery
  • Hemostasis
  • Patient Warming
  • Blood Processing
  • Infusion Pumps
  • Medical Imaging

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Medical & Biotechnology Image Gallery

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Manufacturing & Design Services – Medical & Biotechnology

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