EDEN PRAIRIE, Minn., May 19, 2010 (BUSINESS WIRE) --SurModics, Inc. (Nasdaq: SRDX), a leading provider of drug delivery and surface modification technologies to the healthcare industry, announced that its SurModics Pharmaceuticals facilities in Birmingham, Alabama have been certified by Det Norske Veritas (DNV) Certification, Inc. as compliant to the Quality Management System Standards ISO (International Standards Organization) 9001:2008 and ISO 13485:2003.
"We are pleased to receive these ISO Certifications as part of our on-going efforts to build the infrastructure necessary to support development and production of our partners' medical products," said Bruce Barclay, President and CEO. "Certification of our quality systems by an outside auditing body speaks to our ability to fully leverage the capabilities of our new world-class cGMP manufacturing facility."
The ISO application process requires considerable time and preparation, culminating in a rigorous review by an independent Notified Body. Adoption of International Standards means that SurModics adheres to stringent quality standards that are widely recognized. For our customers, conformity of products and services to these standards provides assurance of quality, safety, and reliability.
The ISO 9001 and ISO 13485 certificates of registration were awarded by Det Norske Veritas Certification, Inc., a leading ISO registrar. They are extensions of the ISO certifications held by our corporate facilities in Minnesota since 2005. According to Barclay, the audit confirmed the Company's compliance with these international standards for quality systems. "Obtaining these Certifications supports the functional consolidation completed in March and will directly benefit our customers well into the future," he said.
About SurModics, Inc.
SurModics' vision is to extend and improve the lives of patients through technology innovation. The Company partners with the world's foremost medical device, pharmaceutical and life science companies to develop and commercialize innovative products that result in improved diagnosis and treatment for patients. Core offerings include: drug delivery technologies (coatings, microparticles, nanoparticles, and implants); surface modification coating technologies that impart lubricity, prohealing, and biocompatibility capabilities; and components for in vitro diagnostic test kits and specialized surfaces for cell culture and microarrays. SurModics is headquartered in Eden Prairie, Minnesota and its SurModics Pharmaceuticals subsidiary is located in Birmingham, Alabama. For more information about the Company, visit www.surmodics.com. The content of SurModics' website is not part of this release or part of any filings the Company makes with the SEC.
Safe Harbor for Forward-Looking Statements
This press release contains forward-looking statements. Statements that are not historical or current facts, including statements about beliefs and expectations, such as those regarding our ability to utilize our manufacturing facility, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and important factors could cause actual results to differ materially from those anticipated, including those identified under "Risk Factors" in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended September 30, 2009, and updated in our subsequent reports filed with the SEC. These reports are available in the Investors section of our website at www.surmodics.com and at the SEC website at www.sec.gov. Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update them in light of new information or future events.
SOURCE: SurModics, Inc.
Phil Ankeny, Senior Vice President and Chief Financial Officer