To ensure the safety and effectiveness of medical device data systems (MDDSs), regulators like the U.S. Food and Drug Administration are requiring organizations that develop or provide medical device data systems to implement a quality management system.
This 38-page recommended practice provides information that allows the medical device data system manufacturer to implement a quality management system that matches the risk presented by the device, the complexity of device and manufacturing processes, and the size and complexity of organization.
Right now, the new ANSI/AAMI SW87:2012 is only available in pdf format, but should be released in paper format from the publishers soon. You can purchase a copy on our website, www.document-center.com. Or contact us for more information by phone (650-591-7600), fax (650-591-7617) or email (email@example.com). We appreciate the chance to help you with your standards requirements and questions.