Medical Device Manufacturer Announces ISO 13485: 2003 Certification

Share Article

Biocoat, Inc. announced ISO 13485: 2003 Certification for the design, development, manufacturing and distribution of its HYDAK(R) coatings for medical device applications and its medical devices for sperm selection and sperm analysis.

Licensees of Biocoat's HYDAK coatings technology can be assured that the management system governing the development and manufacturing of our products meet the highest standards. We expect this ISO certification will also expand the marketing of our reproductive technology products - the PICSI(tm) Sperm Selection Device and the HBA(R) Sperm-Hyaluronan Binding Assay.

Biocoat, Inc. announced ISO 13485: 2003 Certification for the design, development, manufacturing and distribution of its HYDAK(R) coatings for medical device applications and its medical devices for sperm selection and sperm analysis.

"We are pleased to have achieved this certification and regard it as essential to the continued growth of our company," said Djoerd Hoekstra, president and CEO of Biocoat. "Licensees of Biocoat's HYDAK coatings technology can be assured that the management system governing the development and manufacturing of our products meet the highest standards. We expect this ISO certification will also expand the marketing of our reproductive technology products - the PICSI(tm) Sperm Selection Device and the HBA(R) Sperm-Hyaluronan Binding Assay."

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.

Biocoat's hyaluronan technology is also used in the manufacture of two products for Assisted Reproductive Technologies (ART) that aid in the diagnosis and treatment of male infertility. The HBA Sperm-Hyaluronan Binding Assay makes it possible to diagnose certain types of male infertility. And, the PICSI Sperm Selection Device helps embryologists isolate mature, competent sperm for use in the ICSI method of IVF, improving the chances of successful pregnancy.

For more information on Biocoat's HYDAK Coatings or their new PICSI and HBA products, call 215-734-0888, or visit http://www.biocoat.com.

###

Share article on social media or email:

View article via:

Pdf Print

Contact Author

John Zimmermann
Visit website