Polymicro earns U.S. FDA medical device registration

As per FDA 21 CFR 820 QSRs, medical manufacturers must establish and adhere to quality systems that ensure their products consistently meet requirements for current good manufacturing practices. This addresses methods, facilities and controls used in the design, manufacture, packaging, labelling, storage, installation and servicing of finished medical devices intended for use with patients.

Comprising silica capillary tubing, speciality optical fibres, optical and capillary assemblies, discrete micro components and packaged and sterilised components, the Polymicro product portfolio is made with biocompatible materials certified to ISO 10993. Additionally, Polymicro maintains certification in ISO 9001 quality management, ISO 13485 quality management for medical devices, and ISO 14001 environmental management.

Kevin O’Connor, Director of Sales and Marketing, Polymicro Technologies, subsidiary of Molex, commented: “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. 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.”