JuneBrain is thrilled to announce that it has received a $300,000 grant from the Medical Device Innovation Consortium’s Advanced Manufacturing Clearing House program. The funding will support the modernization of JuneBrain’s quality management system in collaboration with Compliance Group (CG) and Siemens Digital Industries. This initiative aims to streamline the company’s path to FDA clearance by incorporating critical feedback from the FDA at key stages of the process.
With Siemens’ Polarion Design Control and Risk Management technology, CG will assist JuneBrain in swiftly implementing a modern, data-centric Design Quality System. CG will provide a comprehensive subscription package tailored for startup medical device and diagnostics companies, which includes software, hosting, support, compliant SOPs for design control and risk management, validation, audit support, annual upgrades, and change management services to ensure effective adoption.
“As a startup with limited resources, accessing advanced, enterprise-grade design quality systems can be challenging,” said Dr. Samantha Scott, CEO of JuneBrain. “This grant award gives us a significant advantage, enabling us to modernize our design quality system, streamline our regulatory pathway, and ultimately enhance patient safety and product quality.”
Jason Spiegler, SVP of Compliance Group, expressed enthusiasm about the partnership: “CG is excited to support JuneBrain in overcoming the unique challenges faced by startups. Our turn-key package aims to reduce regulatory risks, attract investor funding, accelerate commercialization, and prepare startups to respond rapidly to post-market feedback.”
Gerry Keane, Vice President and General Manager at Siemens Digital Industries, added, “We are excited to collaborate with JuneBrain and Compliance Group to enhance design control in medical devices. By combining our digital solutions with their expertise, we’re driving innovation and setting new standards in quality and compliance in neurology and ophthalmology.”
About JuneBrain, Inc.
JuneBrain, Inc. develops optical coherence tomography (OCT) products to extend the reach of neurology and ophthalmology into underserved communities globally.
About Compliance Group Inc:
Compliance Group assists life science manufacturers in achieving quality excellence by providing tailored expertise, processes, and technology. They specialize in streamlining operations, ensuring regulatory compliance, reducing costs, and enhancing system performance across the value chain.
