ND Industries, a leader in advanced fastening and sealing technologies and a business unit of H.B. Fuller, announces that its Los Angeles Fastener Processing Division has officially achieved ISO 13485 certification.
This globally recognised 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.
By securing ISO 13485 compliance at its Santa Fe Springs, CA location, ND Industries is positioned to provide precision coating services to the medical device industry across the United States, North America and globally. Simply ship your uncoated medical-grade fasteners to the Los Angeles division, and ND Industries will pre-apply its specialised 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 the West Coast processing lines, risk assessment protocols and product traceability frameworks align with the highest medical standards.
Medical device design engineers and procurement teams can now utilise ND Industries' fully integrated manufacturing capabilities, benefiting from total product traceability, proactive risk mitigation and regulatory compliance. The Southern California team is fully equipped to apply ND Industries' advanced formulae - including ND Patch, Electroloc and Vibra-Tite VC-3 - under this newly certified medical QMS.