Capsule (www.capsuletech.com), the leading provider of medical device connectivity, announced today that it has received ISO-13485 certification for its headquarters in Paris, France and its US operation in Andover, MA. The certification covers the design, production and sales of data acquisition and processing systems in the medical area. The certificate demonstrates that Capsule has successfully implemented a quality management system that conforms with the worldwide quality management system standard for medical devices. Achievement of ISO certification shows Capsule's continued commitment to the highest level of quality management and design controls to ensure delivery of the safest and most effective products possible.
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."
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