Kerecis Limited Receives ISO 13485:2003 Quality Management System Certification
Reykjavik/Isafjordur, Iceland, March 24, 2011 — Kerecis Limited, the emerging tissue-regeneration company, has received the International Organization for Standardization (ISO) 13485:2003 certificate for the “Design, development and production of wound and hernia treatment products.”
ISO 13485:2003 specifies requirements for “a quality-management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.”
Statistics show a large need for improved wound-care technologies. Each year about 6 million Americans suffer from problem wounds caused by diabetes, circulatory problems and other conditions, with 1.1 to 1.8 million new cases added each year.
More than 20 million Americans have diabetes, almost 20 percent of whom are over the age of 60. Fully 15 percent of all diabetics develop problem wounds, and more than 100,000 diabetics undergo amputation each year because of such wounds in the United States alone.
G. Fertram Sigurjonsson, Kerecis Co-Founder and Chairman of the Board
“The ISO 13485 certification is a requirement for companies supplieng 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.”
Kerecis (https://kerecis.com) is a development and manufacturing business producing a novel, patent-pending tissue-regeneration material derived from fish skin to accelerate the healing of wounds and tissue reconstruction. Kerecis’ material addresses the large unmet need of the double-digit growth biologics segment of the chronic-wounds and hernia-repair markets. 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. For more information, e-mail firstname.lastname@example.org or call 703-879-6535 (U.S.) or 354-8494960 (Iceland).