Contract Manufacturing
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
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Human Factors Engineering
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Human Factors Engineering
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Embedded Cybersecurity
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Embedded Cybersecurity
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Automated Test Systems
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Automated Test Systems
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Electrical
Design
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Electrical
Design
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Systems Engineering
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Systems Engineering
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Mechanical
Design
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Mechanical
Design
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Firmware
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Firmware
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Mobile
Apps
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Mobile
Apps
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Cloud-Based Applications
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Cloud-Based Applications
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