Capsule Achieves Significant Milestone With ISO-13485 Certification
Published: Sep 02, 2009
ANDOVER, MA--(Marketwire - September 02, 2009) -
International Organization for Standardization
Medical Device Connectivity
Peter Kelley, Director of Quality Assurance and Regulatory Affairs at Capsule, explains that, "ISO-13485 places significant emphasis on using risk management to guide product development activities in order to increase patient and user safety. We have implemented a risk management program based on another ISO standard, 14971, which allows us to identify potential hazards and to implement control measures to minimize their likelihood of occurrence. For products like DataCaptor™, that connect directly to medical devices which may be used in life support situations, it is essential to identify and control all possible sources of hazards."
ISO, the International Organization for Standardization (http://www.iso.org/iso/home.htm), is the world's largest standards developing organization with publication of more than 17,500 International Standards, ranging from mechanical engineering, to medical devices, to the newest information technology developments. These standards ensure desirable characteristics of products and services such as quality, environmental friendliness, safety, reliability, efficiency and interchangeability.
The ISO-13485 certification focuses on the unique and rigorous requirements for companies involved in the development of medical devices. Because of the potential risks involved in the flow of data from active medical devices, Capsule believes that device integration should also follow the same requirements and therefore decided it was vital to pursue the certification. And the ISO certification is just one more proof point of Capsule's commitment to quality standards and design controls since Capsule is currently the only medical device connectivity provider with Class II FDA 510(k) clearance. "Capsule continues to design and develop trusted, reliable products for the healthcare IT community," said John Douglass, President of Capsule Tech, Inc. "Meeting the ISO certification standards, as well as the Class II FDA clearance, requires continuous company oversight and significant investment. This milestone is the culmination of over a year's worth of work that involved nearly everyone in the company and confirms our commitment to the highest quality standards. And it will allow us reach our goal of worldwide distribution since the certification allows us to market our products around the globe."
For more information about the importance of quality systems, including Peter's opinion on the impending MDDS certification, please see his blog post discussing the issues of FDA Quality Standards in more detail on the Medical Device Connectivity Blog located at http://medicalconnectivity.com/category/regulatory/. Peter will also be participating in a panel discussion at the upcoming Inaugural Medical Device Connectivity Conference & Exhibition September 10-11, 2009 at the Joseph B. Martin Conference Center at Harvard Medical School.
For more than 12 years, Capsule has been the world's leading, award-winning provider of solutions for medical device connectivity. The company has established market leadership through its FDA 510(k) cleared software and medical grade hardware products, its unique expertise in device protocols and firmware, and through its strong partnerships with major medical device manufacturers and HIS companies. Capsule's solutions are proven, with over 415 installations at leading healthcare facilities worldwide and its technology is secure, with the largest installed device driver library and with proven connectivity to over 30,000 devices and transmission of over 187 billion bits of clinical data. Furthermore, Capsule is continually recognized as the leader in the industry receiving the 2008 Frost & Sullivan Global Technology Leadership Award as well as the Deloitte Technology Fast 50 and Fast 500 EMEA Awards. And, with the introduction of the Capsule Neuron™ platform, Capsule will continue to be the leader, by working with our partners to develop and implement solutions that meet the short and long term patient safety needs of hospitals today. For more information, please visit the company's Web site at http://www.capsuletech.com/ or contact the Company's U.S. Marketing & Public Relations at 978-482-2337.