JuneBrain Receives MDIC Advanced Manufacturing Clearing House Award; Selects Compliance Group to Implement Siemens Polarion Design Quality System
September 06 2024 - 10:35AM
Business Wire
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!
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