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The journey toward IVDR compliance for the LVOne device
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About Upfront Diagnostics
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.
Challenge
Approach
Result
Challenge
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.
Approach
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.
Result
Holder of the ISO 13485:2016 certification
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.
Get in touch
Also want to get ISO 13485 certified?
Discover how our QMS experts can help you or contact us directly. We’d be happy to assist you!
