ND Industries Los Angeles Division Achieves ISO 13485 Certification

ND Industries Achieves ISO 13485 Certification, Medical Device Manufacturing

ND Industries Los Angeles Division Achieves ISO 13485 Certification, Expanding Medical Device Manufacturing Capabilities

SANTA FE SPRINGS, CA – ND Industries, a leader in advanced fastening and sealing technologies and a business unit of H.B. Fuller, proudly announces that its Los Angeles Fastener Processing Division has officially achieved ISO 13485 certification.

This globally recognized standard specifies the strict quality management system (QMS) requirements necessary to supply the medical device industry, validating that a facility can meet rigid safety, traceability, and regulatory criteria.

Meeting the Demands of MedTech

By securing ISO 13485 compliance at our Santa Fe Springs, CA location, ND Industries is uniquely positioned to provide precision coating services to the medical device industry across the United States, North America, and globally. No matter where your business is located, we make the process seamless: simply ship your uncoated medical-grade fasteners to our Los Angeles division, where we will pre-apply our specialized materials to your exact specifications and efficiently return the completed parts directly to your facility.

Medical applications demand zero-fail component reliability. Fastener loosening or fluid leakage in diagnostic machinery, surgical tools, fluid systems, or clinical hardware can compromise patient care. The Los Angeles Division already holds a prestigious AS9100D (Aerospace) with ISO 9001:2015 certification. Adding ISO 13485 confirms that our West Coast processing lines, risk assessment protocols, and product traceability frameworks align with the highest medical standards.

What This Means for Medical Device OEMs

Medical device design engineers and procurement teams can now utilize ND Industries’ fully integrated manufacturing capabilities, benefiting from:

  • Total Product Traceability: Rigorous lot tracking and document control from raw chemical synthesis to final coated fasteners.
  • Proactive Risk Mitigation: Application processes designed to strictly eliminate component failure and product recalls.
  • Regulatory Compliance: Strict alignment with the rigorous quality metrics mandated by medical OEMs and global health authorities.

Our Southern California team is fully equipped to apply our advanced formulas—including ND Patch, Electroloc, and Vibra-Tite VC-3—under this newly certified medical QMS.

View Our Official Certificate

We invite our customers, partners, and compliance auditors to review our official credentials.
👉 Click here to view and download our official ISO 13485 Certificate (PDF)

To discuss your medical assembly specifications or request a quote from our newly certified facility, reach out to the Southern California team at 562-926-3321 or connect via our Contact Us / RFQ Page.

  • ND Industries Los Angeles Division, 13929 Dinard Avenue, Santa Fe Springs, CA 90670.