Kerecis has received the International Organization for Standardization (ISO) 13485:2003 certificate for the ‘design, development and production of wound and hernia treatment products.’
The company produces a novel, patent-pending tissue-regeneration material derived from fish skin to accelerate the healing of wounds and tissue reconstruction.
Kerecis said the material offers advantages over existing human- and porcine-derived products, including improved manufacturing economics and lower risk of disease transfer.
Since it is derived from fish, the material is both kosher and halal compatible, eliminating cultural and religious constraints on usage, with equivalent or better clinical performance.
Kerecis co-founder and chairman of the board G Fertram Sigurjonsson said the ISO 13485 certification is a requirement for companies supplying medical devices to the European market and is rapidly becoming the standard for medical device suppliers in the US also.
"Achieving this certificate validates our commitment to quality, and demonstrates the progress we are making toward establishing our technology as an appropriate treatment for wounds and hernia repair. The certificate also strengthens our ability to enter worldwide markets," Sigurjonsson said.