Medical device company JuneBrain has secured a $300,000 grant from the Medical Device Innovation Consortium (MDIC) through its Advanced Manufacturing Clearing House programme to modernise its quality management system.
The grant will support the modernisation of JuneBrain's quality management system, a critical step towards obtaining clearance from the US Food and Drug Administration (FDA).
The funding will facilitate the integration of feedback from the FDA at crucial stages of the clearance process.
In partnership with Compliance Group (CG) and Siemens Digital Industries, JuneBrain will implement Siemens' Polarion design control and risk management technology to enhance its design quality system.
JuneBrain CEO Dr Samantha Scott said: “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 modernised 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.”
Compliance Group provides a comprehensive subscription package tailored for start-up medical device and diagnostics companies.
This package includes software, hosting, support, and configuration used by leading medical technology companies.
It also encompasses streamlined compliant design control and risk management standard operating procedures that incorporate Polarion, as well as services for administration, governance, validation, audit support, annual upgrades, and organisational change management.
Compliance Group senior vie-president Jason Spiegler: “CG’s goal with this turn-key package is to minimise friction for start-up companies and help de-risk the regulatory pathway, attract favourable investor funding, accelerate commercialisation of their technology, and prepare to rapidly respond to post-market feedback when required.”
Last month, The Financial Times reported that Siemens was planning to purchase the diagnostic arm of Novartis’ Advanced Accelerator Applications (AAA), for a sum exceeding €200m ($224m).
