Paradyne Medical's skilled designers bring decades of experience in the medical device industry.  Complete services include the design and rendering of equipment, fixtures and components at multiple levels - from concept to prototypes to fully commercialized products.

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Quality Control

We are an FDA registered, ISO 13485 certified medical device manufacturer of sterile and non-sterile devices.  We utilize a state of the art TQM system and continuous improvement to keep our customers in compliance with all regulations.

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Operating in our state of the art, HEPA filtered, ISO certified cleanroom, Paradyne Medical provides full turnkey services including manufacturing, engineering, sterilization and validation. 

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Supply Chain Management

Paradyne Medical understands that one of the keys to success for any product is having a robust supply chain that offers end-to-end supply chain management including procurement, inventory management, and fulfillment.

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Technical Specialties Include:

Additional services available.

Product Development Services

Paradyne Medical offers the following Design and Development services to facilitate your new product market launch:

  • Early-stage feasibility studies, including design and fabrication of models
  • Product design
  • Prototype fabrication and testing
  • Development of product specifications
  • Design verification, including development of test protocols and testing
  • Tooling, equipment and fixture design and fabrication
  • Process development and validation, including documentation and testing
  • Packaging design and validation support
  • Sterile validation support
  • Component and raw material selection and sourcing
  • Design history file
  • Biocompatibility testing support
  • Regulatory support; 510(k), CE Mark, PMA
  • Manufacturing
  • Technology Transfer

Developmental Product Testing

Paradyne Medical offers a full range of compliance and performance testing capabilities to fully support the development of catheter-based systems and medical devices.  Whenever applicable, our test protocols incorporate the latest ISO standards.  Product testing services include:

  • Test protocol and custom test method development
  • Tensile testing
  • Leak and pressure testing
  • Dimensional testing
  • Performance testing