The journey toward IVDR compliance for the LVOne device

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.