QbD Group helped Upfront Diagnostics gain entry into the MD/IVD industry by supporting them on their path to ISO 13485 certification.
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.
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.
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.
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.
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
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