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OUTSOURCE YOUR MEDICAL DEVICE R&D

Kapstone partners with organizations of all sizes to rapidly develop and commercialize new medical devices, on time and on budget. We provide services for all aspects of products development & distribution, including quality assurance, regulatory affairs, supply chain management and IP Protection.

 

Why Kapstone?

    •   Exposure to new ideas stimulating innovation

 

    •   Cost reduction – You pay for deliverables not overhead

 

    •   Reduced time to market and better management of risk

 

    •   Access to new engineering skills and Intellectual Property options

 

    •   Flexibility
Have Kapstone Handle your outsourcing.
Conceptualization & Feasibility Study

Kapstone will work with your Engineers on clearly defining the parameters of the project, clarifying the concepts behind your new technology to swiftly arrive at a precise definition.

A comprehensive assessment of the device is performed. Our engineers ensure that the concept works from both a biomechanical and clinical use perspective, and propose solutions to challenges.

Design & Development

Kapstone design team is highly experienced with 3D modeling CAD software, SolidWorks. The company strives on providing elegant, innovative solutions to mechanical problems.

3D Rapid Prototyping

Kapstone in-house 3D Rapid Prototyping equipment is a key asset to the Kapstone value proposition allowing the project to move swiftly and efficiently throughout its different phases.

Our Rapid Prototyping machine uses a standard data interface, implemented as the STL file format, to translate from the CAD software to the 3D prototyping machine. The STL file approximates the shape of a part or assembly using triangular facets.

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Testing & Regulatory Submission

Kapstone has established relationships with the most reputable Testing labs in the country.

Expertise & experience drive successful FDA submission processes. Kapstone possesses both. Our team can prepare and submit 510(k) documentation on your behalf to address FDA requirements and anticipate potential questions, leading to on-time and on-budget regulatory approvals timelines. Our record speaks for itself. Call us now for more details.


CAPABILITIES

  • Project Management
  • Intellectual Property
  • Strategy
  • Conceptualization
  • Feasibility Studies
  • CAD Design
  • Finite Element Modeling
  • Rapid Prototyping
  • Biomechanical Testing
  • In-vivo Study Development
  • Quality System
  • Development
  • Regulatory Strategy
  • FDA Submission
  • CE Marking
  • Vendor Management
  • Manufacturing
  • Logistical Support
  • Global Expansion
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