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Medical Device Manufacturing & Factory Optimization

How to Make Your QMS Work for You

Meet Our Leader in Manufacturing & Quality Management Systems

Randy Armstrong

Randy is Velentium’s Chief Technology Officer and is responsible for creating our Quality Management System, which we believe is one of the leanest and most effective in the industry. He has a passion for the elegant solution – one that is simpler, consumes less energy, has fewer components, is smaller, requires less maintenance, and costs less - producing designs which become flagship and platform technologies that return value far beyond original goals.

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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:

Pilot builds & first runs for device clinical trials

Design factory test systems optimized for efficiency, quality assurance, and compliance

Develop and validate manufacturing procedures

Help sustaining products by providing customer service hotlines and technical support

Industy Leading Expertise

Why Build With Us

Design & Development Experts within Arms’ Reach At All Times

  • Fast, superior factory support from our SMEs
  • Time-critical commitment by manufacturing management
  • Secured manufacturing process and supply chain oversight
  • Test coverage verification and manufacturing systems design
  • Insight for next-generation design available from our systems engineering team

Leverage our ISO 13485 QMS

  • Ensure your design is optimized for efficient, cost-effective manufacturing
  • Quickly uncover & address any design, process, or supply chain concerns
  • Control materials, documentation, and supply chain for QA & compliance
Learn How We Can Help

Start Your Manufacturing Project Today!

PARTNER WITH US TODAY!
Blog - Thought Leadership & Expertise

Thought and Commentary for the Medical Device Industry

An Introduction to Human Factors Engineering for Medical Devices

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Introduction to Static Analysis

Regardless of industry, any company writing code understands the need for standardization and proof-checking, and the medical device sector is no...

Human Factors Engineering (Part 3): Validation Testing

In our previous posts, we looked at the importance of integrating human factors engineering (HFE) processes throughout product development. FDA...

Human Factors Engineering (Part 4): 7 Additional Resources

When developing a new device using Human Factors Engineering (HFE), researching known use- and design-related issues and hazards that have already...