Your Vision. Designed. Delivered.

Xeridiem orchestrates design and regulatory documentation.
Creates the DESIGN HISTORY FILE.  

Choose from our PRODUCT REALIZATION Menu of Services

  • Development plan and budget for project management
  • Resource identification and design requirements
  • Design for manufacturability
  • Validation and verification
  • Process Failure Mode and Effects Analysis (PFMEA)
  • Product specifications (design outputs)
  • Manufacturing plan
  • Package design
  • IFU (instructions for use)
  • Learn more about our process

 

 

Xeridiem Supports your REGULATORY Submission

  • Writing applications for 510(k), CE, etc.
  • Documentation submission
  • Receiving registrations
  • Biocompatibility and cytotoxicity testing
  • Learn more about our regulatory expertise

 


XERIDIEM DELIVERS THE DESIGN HISTORY FILE FOR YOUR DEVICE.


Please contact us at +1-520-882-7794 and info@xeridiem.com if you're interested in learning more about how we can help.