JuneBrain Receives MDIC Advanced Manufacturing Clearing House Award; Selects Compliance Group to Implement Siemens Polarion Design Quality System

LIBERTYVILLE, Ill.–(BUSINESS WIRE)–#SaMD–JuneBrain is excited to announce our selection to receive a grant award from the Medical Device Innovation Consortium’s Advanced Manufacturing Clearing House program! The $300,000 award has been afforded to support the modernization of our quality management system in collaboration with Compliance Group (CG) and Siemens Digital Industries. The provided funding will help to de-risk and streamline our trek to FDA clearance, including facilitation to incorporate feedback from the FDA at key junctures of the process.

Using Siemens best-in-class Polarion Design Control and Risk Management technology, CG will work with JuneBrain to rapidly implement and drive adoption of a modern digital datacentric Design Quality System. CG will provide a turn-key holistic subscription package specifically designed for Start-Up Medical Device and Diagnostics companies. In addition to software, hosting, and support, the package includes the same out-of-the-box configuration used by many leading Medical technology companies, a suite of stream-lined compliant Design Control and Risk Management SOPs incorporating the use of Polarion, administration, governance, validation, audit support, annual upgrade services, and organizational change management services to drive effective adoption.

“As a startup with limited resources, it can be immensely challenging to access advanced, enterprise-grade design quality systems that are critical for navigating the regulatory landscape and ensuring patient safety. However, JuneBrain’s selection for the MDIC grant award will give us a significant advantage. Our partnership with Compliance Group and Siemens will enable us to implement a modernized design quality system, streamlining our path to FDA clearance and improving operational efficiencies. Ultimately, this will enhance patient safety, the quality of our products, and create long-term value for our stakeholders,” says JuneBrain CEO, Dr. Samantha Scott.

“CG is very excited to work with the JuneBrain team on this impactful project! Having personally worked for 3 start-up Medical Device companies, their challenges in bringing their first product to market are significantly magnified when compared with larger companies. CG’s goal with this turn-key package is to minimize friction for Start-Up companies and help de-risk the regulatory pathway, attract favorable investor funding, accelerate commercialization of their technology, and prepare to rapidly respond to post-market feedback when required,” says Compliance Group’s SVP, Jason Spiegler.

“Siemens is thrilled to partner with JuneBrain and Compliance Group to enhance design control in medical devices and the OCT space. This collaboration combines our digital transformation solutions with their expertise, driving innovation and ensuring the highest standards of quality and compliance in the neurology and ophthalmology segments. Together, we’re paving the way for safer, more effective healthcare solutions,” says Gerry Keane, Siemens Digital Industries Group Vice President and General Manager.

About JuneBrain, Inc.

JuneBrain, Inc. specializes in developing optical coherence tomography (OCT) products that expand the reach of neurology and ophthalmology into underserved communities around the world. Learn more about JuneBrain, Inc. at https://www.junebrain.com/

About Compliance Group Inc:

Compliance Group helps life science manufacturers create the most efficient path to quality excellence across the value chain by delivering the exact expertise, process, and technology required. CG specializes in providing comprehensive services and solutions that streamline operations, ensure regulatory compliance, reduce costs, and enhance overall system performance.

Learn more about Compliance Group Inc at https://www.complianceg.com/

About Siemens Digital Industries:

Siemens Digital Industries Software helps organizations of all sizes digitally transform using software, hardware and services from the Siemens Xcelerator business platform. Siemens’ software and the comprehensive digital twin enable companies to optimize their design, engineering and manufacturing processes to turn today’s ideas into the sustainable products of the future. From chips to entire systems, from product to process, across all industries. Siemens Digital Industries Software – Accelerating transformation.

About MDIC

Seeking support for your own journey to market and beyond? We’d like to encourage all medtech startups to take a closer look at the Advanced Manufacturing Clearing House (AMCH) Program, whose mission, in collaboration with the FDA, is to promote the use of advanced technologies in the medical device ecosystem, driving improvements throughout the total product life cycle. Your company could be the next awardee—learn more and apply today at MDIC.org/AMCH!

Contacts

info@complianceg.com