Gamma Medica's LumaGEM Molecular Breast Imaging Solution Honored as Finalist in the Medical Design Excellence Award - Sunrise Labs, Inc. cited for its role in product development
AUBURN, NH, US - Jun 2, 2014 - Sunrise Labs is pleased to announce that their client, Gamma Medicas 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 Medicas 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 Sunrises 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.
Sunrise Labs solves tough engineering problems, nimbly and with integrity. Our teams deep experience developing Medical Devices accelerates ideas to market, on a direct path, using the most appropriate technologies, while fully addressing safety, reliability, and regulatory compliance. Projects range from portable, wireless, battery powered devices, to complex systems with high-performance analog conditioning; controls; real-time, multi-tasking software; and intuitive User Interfaces. From wireless body mounted sensors, to smart phone apps, to cloud based data repositories, Sunrise integrates systems to reliably deliver medical services when and where they are needed. For over 22 years, clients have come to Sunrise Labs again and again for medical product development, and Project Rescue. Its their success that tells the Sunrise Labs story. Sunrise is ISO-13485 and ISO-9001 certified.
The people at Sunrise Labs were a pleasure to work with, and the team was very responsive to project changes. Their deep, technical knowledge and capabilities relative to the needs of the LumaGem were excellent, and their contribution to our Quality and Regulatory initiatives was immeasurable.
-Steve Dallas, Director of Engineering
The MDEA is the medtech industrys premier design competition committed to searching worldwide for the highest caliber finished medical devices, products, systems, or packaging available on the market. The awards program celebrates the achievements of the medical device manufacturers, their suppliers, and the many people behind the scenes-engineers, scientists, designers, and clinicians-who are responsible for the cutting-edge products that are saving lives; improving patient healthcare; and transforming medtech-one innovation at a time.