PERKASIE, Pa.--(BUSINESS WIRE)--US BioDesign, a global leader in the production of biomedical textile structure components today announced that they have received their ISO 13485:2003 Certification.
US BioDesign, already a leader in driving innovation, design and efficiency in the engineering, development and production of medical textiles, fabrics, and biomedical structures has now been awarded the highest International Organization for Standardization (ISO) classification for the development, control and maintenance of internal quality control systems relating to: custom engineering and manufacturing of biomedical textile components for medical device manufacturers, including the cardiovascular, orthopedic, general surgery and neurological medical device markets.
US BioDesign’s best-in-class medical development and manufacturing technologies have allowed them to drastically reduce design and production times for their partners by creating a process of working collaboratively. Together, US BioDesign and its partners reduce production times and deliver a product to market more quickly than their competitors. By focusing and attaining their ISO 13485 certification, US BioDesign continues to demonstrate to their partners this unwavering commitment to excellence.
“This is an exciting milestone for US BioDesign. We operate under the premise that time is money. This classification further demonstrates that as we continue to refine our internal and external processes we continue to set the industry benchmark in both. Our successes, both internally and externally, in a very short amount of time demonstrate that US BioDesign was founded, developed and continues to evolve along the stringent expectations set for us by our customers,” states Tom Molz, President & CEO of US BioDesign.
“US BioDesign’s mission is to be the most effective OEM supplier of biomedical textile structures in the industry, US BioDesign’s 13485 designation demonstrates the vigor by which we are pursuing our goals,” added Molz.
About US BioDesign
US BioDesign is a global leader in the development and manufacture of biomedical textile structure components for medical devices. US BioDesign delivers the right solution to solve customer problems with unmatched timeliness and efficiency as a result of its biomedical engineering expertise and an unparalleled understanding of medical device construct development involving polymeric and/or metallic raw materials. US BioDesign serves the cardiovascular, orthopedic, general surgery and neurological device segments of the health care industry.