Our Medical Device Services

Medical Device Manufacturing ServicesAccumedix, Inc. provides a full range of services from design assistance through manufacturing and order fulfillment to the medical device industry to get your product to market. Specific services include,

Design and Development

  • Overall program and project management
  • Design for cost and manufacturability
  • Manufacturing and assembly procedures
  • Testing procedures

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Quality Management System

  • 510K, regulatory submissions and device listings
  • Regulatory facility registrations
  • Device master record/Device history record
  • Act as management representative to FDA

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Assembly and Packaging

  • Sterile packaging
  • Sterilization coordination
  • Warehousing with full lot control
  • Sterilization validation

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Contract Manufacturing

  • Clean room and non-clean room manufacturing
  • Clinical trial through full production scale
  • Full lot control and/or serialization
  • In-process and final quality assurance

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Marketing and Distribution

  • Complete website design and management
  • Internet based eCommerce
  • Independent sales reps available
  • Finished goods warehousing

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