ISO 13485:2003 defines the standards for a quality management system for organizations providing medical devices and related services that consistently meet customer and regulatory requirements.
According to Bob Ruppenthal, RTEmd’s president, “RTEmd’s work is exclusively for manufacturers of medical devices, each of whom typically abide by this standard. This new certification will enable us to add more value in partnership with our clients by being certified against the same standard they uphold.”
Effective software process and continuous improvement has been a cornerstone of RTEmd for 30 years. In 2002 their quality system was certified compliant with the ISO 9001 standard. Last year they recognized the opportunity to once again raise the bar by embracing ISO 13485, which includes ISO 14971 for product risk management. The company was successfully audited by BSI and this month received certificates for both 9001 and 13485.
RTEmd, located in Pittsford, NY, is a primary member of MedTech—the hub of Upstate New York’s Bio/Med industry—with expertise in medical device consulting and high-quality software solutions for manufacturers of medical devices.
RTEmd provides custom software design, development and testing for complex medical equipment. We focus on machine control, image and information management for medical imaging, microbiology and other life science applications. Our project-based services span the entire life cycle, from product requirements to software architecture, code construction, verification testing and documentation. For more information, visit http://www.rtemd.com.
MedTech is an active association of pharmaceutical, biotech, and medical technology companies, their suppliers and service providers, and research universities. We boost the growth and prosperity of our members by connecting them for collaboration, offering educational programs, sharing news and information, and advocating for the industry with government and leaders. Our mission is to develop the relationships, tools and programs that enable Upstate New York companies to bring tomorrow’s medical solutions to the healthcare marketplace. For more information, visit http://www.medtech.org.
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MedTech is an active association of pharmaceutical, biotech, and medical technology companies, their suppliers and service providers, and research universities. For more information, visit http://www.medtech.org.