Medical Device Manufacturing

Promote Your Project from Prototype to Product

U.S.-Based Medical Device Manufacturing

 

Our Facility

  • FDA Manufacturer of Record
  • CFR 820 Compliance
  • Class-7 Clean Room
  • Laser Welding (Class 3 Implants)
  • 12,500 sq ft and growing!

 

Our Services

 

  • Full DMR Creation
  • Transfer to MFG
  • DHR Management
  • Pilot Builds & First Runs
  • Scaled Production for Clinical Trials
  • Main Production
  • Box Build & Drop Ship
  • Return Product Analysis
  • Sustaining Product Technical Support & Customer Service

Make Your Device Real

Partner with Velentium

Medical Device Companies Choose
Velentium Manufacturing

Design & Development Experts within Arms’ Reach At All Times

  • Fast, superior factory support from our SMEs
  • Secure manufacturing process
  • Supply chain accountability and oversight
  • Test coverage verification and manufacturing systems design
  • Insight for next-generation design from our systems engineering team

ISO 13485 Certified QMS

  • Ensures your design is optimized for efficient, cost-effective manufacturing
  • Quickly uncovers & addresses any design, process, or supply chain concerns
  • Controls materials, documentation, and supply chain for quality assurance & compliance
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Projects

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Clients

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Countries

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Grupo 6330
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