Contract Manufacturing

ONE-STOP SHOP FOR END-TO-END MEDICAL DEVICE DESIGN AND DEVELOPMENT.
Our Services

Contract

Manufacturing

Let Velentium meet your manufacturing needs with our ISO 13485-certified lean QMS and our design and development experts within arms’ reach at all times. We are an FDA manufacturer of record and have over 12,500 sq. ft. of dedicated manufacturing space ready to be used for your project!

Manufacturing Facility

  • FDA Manufacturer of Record
  • CFR 820 Compliance
  • Class-7 Clean Room
  • Laser Welding (Class 3 Implants)
  • Full DMR Creation
  • Transfer to MFG
  • Box Build & Drop Ship
  • DHR Management
  • Return Product Analysis

Our Services Include

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Pilot Build & First Runs For Device Clinical Trials

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Develop And Validate Manufacturing Procedures

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Design Factory Test Systems Optimized For Efficiency, Quality Assurance, And Compliance

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Help Sustaining Products By Providing Customer Service Hotlines And Technical Support

Meet the Experts

Contract manufacturing with design & development experts in arms’ reach at all times

 

terry

Terry Daglow

VP, Advanced Mechanical & Manufacturing Engineering

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sat

Satyajit “Sat” Ketkar

Director, Systems Engineering

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Quality Driven

ISO 13485 Certified

Not only do we follow the standards, we helped write them! We adhere to them smartly – with compliant efficiency.

Download ISO 13485 Certificate

Certified to: ISO 13485 – Quality Management Systems
Compliant with: ISO 14971 - Risk Management, IEC 62304 - Software, IEC 60601 - Electrical, IEC 62366 - Useability, ISO 14708 - Active Implantables, ISO 27001 - Information Security Management