Ende Profab, Inc.
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Ende Profab, Inc.
  • Home
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  • Past Projects
  • About Us
  • GSA

Medical Device & Product Commercialization

Taking new medical product concepts, university tech transfer, product redesigns or obsolete/quality improvement initiatives from the drawing board and into production providing all the required disciplines and a single point of contact.

 
Manufacturing Strategy

Volume/geographic rationalization & optimization

Insource/outsource analysis

Make vs. buy analysis

services

Product Management

Manufacturing Management

Manufacturing Management

  • Coordination of multiple disciplines in parallel
  • Timeline & budget management
  • Multi-phase approach to timeline & budget
  • Coordinate with regulatory agencies
  • Manage independent test labs for safety & compliance.

Manufacturing Management

Manufacturing Management

Manufacturing Management

  • Execute appropriate tooling strategy
  • Top level & sub-assembly BOM's
  • Schematic, gerber & assembly documentation
  • Top & sub-level assembly drawings
  • Coordination of product launch into production

Engineering Design

Engineering Design

Engineering Design

 

  • Product concept definition
  • Electronic architecture design
  • Mechanical concepts with electronic integration
  • Proof of concept/prototyping
  • 3D printing/proof of concept
  • Hardware/firmware development
  • Mechanical/electronic integration
  • Development of complete build & test package

Logistics Support

Engineering Design

Engineering Design

 

  • Labeling, traceability
  • Packaging development & implementation
  • Warehousing, shipping/logistics support  


Regulatory Compliance Support Management

  • Manage emissions testing (UL, CSA, CE)
  • Manage safety testing (UL60601, FDA)
  • Manage/trouble shoot compliance & product testing

Ende Profab, Inc. - P.O. Box 251 - Roswell, GA 30077 - (678) 427-9954


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