Gamma Medica needed a project management team to create a development plan for their software architecture and to implement a Quality Management System in line with US FDA, ISO-13485 and EU directives and to meet international, state and federal requirements.
Sunrise Labs Solution
- Created architecture and software lifecycle plans
- Aligned software requirements with IEC 62304
- Generated and implemented test plans, protocols, and reports
- Coordinated, documented and implemented Quality and Regulatory initiatives with US FDA, ISO-13485 & EU Directives
- Led IEC 60601-1 3rd Edition Testing, Documentation & Certification
- Supported electronics design for compliance
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American Journal of Roentgeneology (AJR) retrospective study confirmed Gamma Medica's Molecular Breast Imaging (MBI) technology had high incremental cancer detection rate of 7.7 cancers per thousand (7.7/1000) and overall clinical effectiveness as a secondary screening tool in finding 13 malignancies among 1,696 women with dense breast tissue following mammograms that read negative for cancer.
Mayo Clinic study determined that the addition of Molecular Breast Imaging (MBI) for women with dense breast tissue resulted in a lower cost per cancer detected than screening with mammography alone. The study found MBI technologies led to more accurate diagnosis rates, and in combination with mammography resulted in a cost savings of approximately 15 percent.
2014 MEDICAL DESIGN EXCELLENCE AWARDS Bronze Winner
A simple, safe and accurate technology that will save lives