Full Spectrum Software is an ISO 13485-certified medical device development company based in Southborough, Massachusetts, with over 40 years of experience in the medical technology and life sciences sectors. The company operates as a full-responsibility development partner, handling the complete lifecycle of medical devices, life sciences equipment, and digital health solutions from concept through regulatory approval and market deployment.
The company's technical capabilities span multiple domains relevant to modern medical robotics and automation, including robotic systems development and integration, AI and machine learning implementation aligned with FDA guidance, and cybersecurity for connected medical devices. Their service portfolio includes health information systems, medical mobile applications, and regulatory compliance support under ISO 13485 standards. All development work follows processes structured to meet FDA and industry best practices for medical device validation and quality management.
Under CEO Adam Hesse's leadership, Full Spectrum reported over 30% revenue growth in the first half of 2023. The company positions itself as an end-to-end partner for organizations navigating the intersection of medical device development, regulatory compliance, and emerging technologies in healthcare applications. Their ISO 13485 certification demonstrates established quality management systems required for medical device manufacturing and development.