Sunrise Labs Inc. cited for its role in product development
Sunrise Labs is pleased to announce that their client, Gamma Medica’s LumaGEM Molecular Breast Imaging (MBI) Solution has been selected as a finalist in the Radiological and Electromechanical Devices Category of the 17th Annual Medical Design Excellence Awards competition. Finalists were officially announced in the April Issue of MD+DI (Medical Device and Diagnostic Industry) magazine. Winners will be announced at the 2014 MDEA Ceremony held Wednesday, June 11, 2014 in conjunction with the MD&M East event at the Jacob K. Javits Convention Center in New York.
The LumaGEM is an effective and exciting new imaging technology that has great promise for more accurate and earlier breast cancer diagnosis. With the commitment of making molecular breast imaging (MBI) more widely available as a diagnostic tool in the battle against breast cancer, Gamma Medica’s mission is to change the outlook for women whose early stage tumors may go undetected or unconfirmed with a traditional mammogram.
Sunrise Labs worked with Gamma Medica to create the development plan for software architecture and the requirement of the software to be aligned with ISO-62304. Acting in a project management role, Sunrise coordinated, documented and implemented the Quality Management System in line with US FDA, ISO-13485 and EU directives, including various International, State and Federal requirements. Sunrise also supported testing, documentation and the IEC 60601, 3rd Edition certification of the LumaGEM.
“Better detection of breast cancer and saving lives is what Sunrise’s medical device development engineers live to do! Thank you Gamma Medica for allowing Sunrise to be part of this effort; we are proud to be on your team.” – Eric Soederberg, Vice President, Sunrise Labs Inc.