Coating manufacturer Biocoat Inc, Horsham, Pa., (biocoat.com) has received ISO 13485: 2003 Certification for the design, development, manufacturing, and distribution of its Hydak coatings for medical devices. The certification includes devices for sperm selection and analysis. “We regard the certification as essential to the continued growth of the company,” says Biocoat president and CEO Djoerd Hoekstra. “Licensees of the Hydak coatings can be assured that the management system governing the development and manufacturing of our products meet the highest standards.”

Hydak coatings are used on vascular catheters, guidewires, sensors, and surgical devices. Based on the natural biopolymer hyaluronan, the coatings are hydrophilic, lubricious, biocompatible, and offer consistent performance on a broad range of polymeric and metallic substrates.