Polymicro Technologies, a subsidiary of Molex, announced its recent registration and compliance with the US Food and Drug Administration (FDA) 21 CFR 820 Quality System Regulation (QSR).
Under FDA 21 CFR 820 QS regulations, medical manufacturers must establish and adhere to quality systems that ensure their products consistently meet requirements for Current Good Manufacturing Practices (CGMP).
CGMP governs methods, facilities and controls used in the design, manufacture, packaging, labeling, storage, installation and servicing of finished medical devices intended for use with patients.
Polymicro Technologies sales and marketing director Kevin O’Connor noted from initial component design through volume production, Polymicro products deliver medical device OEMs total manufacturing solutions and superior products registered and certified to the highest levels of quality assurance.
O’Connor adds, "at Molex, we earn customer trust through a steady pipeline of innovative components that meet or exceed industry standards to help ensure safe and effective medical devices."
The Polymicro product portfolio includes silica capillary tubing, specialty optical fibers, optical and capillary assemblies, and discrete micro components, in addition to packaged and sterilized components.
Made with biocompatible materials certified to ISO 10993, Polymicro optical fiber probes and silica capillaries deliver solutions to meet stringent invasive medical device requirements. Polymicro also maintains certification in ISO 9001 quality management, ISO 13485 quality management for medical devices, and ISO 14001 environmental management.