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 QMS and our design and development experts in-house and on-call. We have over 15,000 sq. ft. of operating space for IPG, Lead, Quality Test, and other Medical Device manufacturing processes.

Our Capabilities Include:

  • FDA Manufacturer of Record
  • CFR 820 Compliance
  • Class 7 Clean Room
  • Laser Can Welding
  • Electrode Welding
  • Helium Leak Detection
  • Injection Molding
  • Liquid Silicone Rubber (LSR) Molding
  • Implantable Leads
  • Full DMR Creation
  • Manufacturability Analysis
  • Box Build & Drop Ship
  • DHR Management
  • Return Product Analysis

Choose Velentium for:

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Pilot Build & First Runs For Clinical Trials; Main Production; On-Shore Manufacturing

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Design for Manufacturability Analysis; Development and Validation of Manufacturing Procedures

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Customized Factory Test Systems with Intelligent Monitoring, Remote Access, Real-time Reporting, & Data Analytics

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Customer Service Hotlines And Technical Support for Sustaining Product Engineering

Meet Our 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! Intelligent, efficient, compliance.

 

Download ISO 13485 Certificate

 

Certified:

ISO 13485 – Quality Management Systems

 

Compliant:

ISO 14971 - Risk Management

IEC 62304 - Software

IEC 60601 - Electrical

IEC 62366 - Useability

ISO 14708 - Active Implantables

ISO 27001 - Information Security Management