Certifications & Methodologies

You can feel confident the products you get will be high quality.

As a U.S.-based FDA compliant medical device contract manufacturer, our facility meets the highest standards for secure and regulatory compliant manufacturing of complex medical devices.

We have ISO 13485 certification, which signifies Mountainside Medical has met the mandatory requirements for comprehensive quality management system in the design and manufacture of medical devices.

Finally, all of our testing equipment and gauges are calibrated to meet ISO 17025 requirements with NIST traceable certificates.

Quality guided by improvement practices and methodologies.

Our commitment to quality is reflected in the implementation of these methodologies and processes:

  • Six Sigma Lean Methodology
    Six Sigma Lean Methodology is a production practice that uses process methodology to improve quality, eliminate waste, enhance workflow, reduce time, and minimize costs. It is a complete set of tools for preserving value with less work and less waste. We use the Six Sigma methodology called DMAIC (define, measure, analyze, improve, control = “duh-may-ick”) for our quality management.
  • Kaizen Methodology
  • Statistical Process Control (SPC)
    With SPC, we can address issues before they arise. It pinpoints any variations, allowing us to manipulate variables and better control output.

Learn about our inspection & validation processes