The journey toward IVDR compliance for the LVOne device
Upfront Diagnostics
In 2022, QbD Group partnered with Upfront Diagnostics, powered by PockitDx, a company specializing in stroke detection caused by Large Vessel Occlusion (LVO).
Upfront Diagnostics enlisted QbD Group’s expertise to achieve IVDR compliance for the LVOne. This innovative device can detect an acute stroke within 15 minutes, enabling swift patient transfer to specialist medical facilities. This rapid intervention not only saves lives and prevents disabilities but also significantly reduces medical treatment costs.
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Achieving IVDR Compliance & ISO 13485 Certification
Upfront reached out to QbD Group for comprehensive support in implementing all aspects of the In Vitro Diagnostics Regulation (IVDR), as well as their Quality Management System (QMS) and their pursuit of ISO 13485 certification.
As Upfront Diagnostics was still in the early stages of development, we made a concerted effort to be deeply involved, ensuring that their IVDR compliance journey began right from the initial design and development phases.
We partnered with QbD IVD | Qarad to establish a robust Quality Management System (QMS) framework compliant with ISO 13485. Their expertise proved invaluable in navigating the certification process and ensuring our novel IVD 'LVOne' met all verification and validation requirements. This successful collaboration has empowered us to bring our innovative product to market with confidence, knowing it adheres to the highest quality and regulatory standards.
Edoardo Gaude – Chief Science Officer at Upfront Diagnostics
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Empowering Success Through Training and Support
QbD Group assigned Regulatory and Quality experts to work closely with Upfront Diagnostics’ in-house team. This collaboration helped them achieve ISO 13485.
By being involved from the outset, our experts provided guidance whenever issues arose during development or studies. We identified critical factors to ensure a smooth IVDR certification process. Additionally, QbD Group’s QA Department played a key role in auditing and qualifying various suppliers.
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Holder of the ISO 13485:2016 Certification
The ISO 13485 certification was successfully obtained in December 2023. The goal is to submit for IVDR certification to BSI by the end of 2024. QbD Group and Upfront Diagnostics continue to work closely together, collaborating on the documentation required by Annexes II and III of the IVDR to ensure timely submission to BSI.
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