ISO Certifications

• Echo Therapeutics Inc. has achieved ISO 13485:2003 certification, which acknowledges the company’s quality management system for the manufacture of medical devices. The company, which is based in Philadelphia, Pa., is developing the Symphony CGM system, a non-invasive, wireless, transdermal continuous glucose monitoring system. “This achievement demonstrates Echo’s continued commitment to meeting and exceeding the high standards required of medical device companies selling into Europe,” said Stephen Perez, Echo’s vice president of quality assurance. “We believe that receiving ISO 13485 certification is a significant accomplishment and an important milestone as we approach the European pivotal trial and commercialization of our Symphony CGM System.” The Symphony system is targeted at patients who could benefit from glucose monitoring in the hospital setting, including critical care.According to the company, significant opportunity also exists for patients with diabetes to use Symphony in an outpatient setting.Echo also is developing its needle-free skin preparation component of Symphony, the Prelude Skinprep system, as a platform technology to enhance drug delivery of topical pharmaceuticals.

• Weiman Products LLC has earned ISO 13485:2003 certification for its quality management system. The company, based in Gurnee, Ill., provides custom formulations and private label cleaning and care products for surgical instrumentation and healthcare environments. The company also manufactures intermediate and high level disinfectants that reduce the risk of infection from cross-contamination by eliminating disease-causing microorganisms. “The certification is the culmination of many months of work by our dedicated Weiman team,” said Carl DeMasi, president and CEO of Weiman Products. “It better positions us to support our medical customers, especially in the manufacturing of FDA [U.S. Food and Drug Administration]-regulated medical devices. Although the certification was awarded for our healthcare products, we manufacture our consumer products to the same high standard.”