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 6 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:

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

Design for Manufacturability Analysis; Development and Validation of Manufacturing Procedures

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

Customer Service Hotlines And Technical Support for Sustaining Product Engineering

Human Factors Engineering

Human Factors Engineering

Embedded Cybersecurity

Embedded Cybersecurity

Automated Test Systems

Automated Test Systems

Electrical
Design

Electrical
Design

Systems Engineering

Systems Engineering

Mechanical
Design

Mechanical
Design

Firmware

Firmware

Mobile
Apps

Mobile
Apps

Cloud-Based Applications

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