In Vitro Diagnostics

Does your company need assistance in meeting the requirements of the European Regulation for In Vitro Diagnostics?

Qarad – part of the QbD Group – can explain the requirements, perform gap assessments of your QMS, review and/or compile your technical documentation, organize performance studies and act as your authorized representative in the EU.

Discover how Qarad, part of the QbD Group, can support your company in In Vitro Diagnostics below.

Challenges in In Vitro Diagnostics

INCREASING EU REQUIREMENTS

The In Vitro Diagnostics industry is rapidly evolving thanks to technological innovations and new medical insights.

In 2017, the European Union published a new regulation for IVD, the IVD Regulation 2017/746. It represents a steep increase in the requirements, necessitating good regulatory competence and resource availability to keep the time-to-market as short as possible.

Qarad can assist your company in all your regulatory challenges from design to CE certification, from idea to patient.

Our Companion Diagnostics Services

FROM STRATEGY TO COMMERCIAL SUCCESS

Qarad, part of the QbD Group, provides comprehensive companion diagnostics services to support you during this complex journey. Our Qarad IVD experts have extensive experience in performance evaluation studies, regulatory affairs, and market access strategies, allowing us to provide customized solutions to meet your needs.

Performance Evaluation Studies & Regulatory Strategy

Qarad can assist you in designing and implementing a performance evaluation study, including Scientific Validity Reporting, Clinical Performance Studies and Analytical Performance Studies. We can also assist you in providing strategic regulatory advice in the development of your companion diagnostic.

Market Access &
Reimbursement

We understand that obtaining reimbursement for companion diagnostics is critical to the commercial success of a personalized medicine product. Our team can assist you in developing a market access strategy that takes into account regulatory and reimbursement requirements in different geographies. We can also provide guidance on health economic assessments, pricing and reimbursement negotiations, and payer engagement.

Why Qarad, part of the QbD Group?

OVER 30 YEARS OF EXPERIENCE IN IVD

Qarad – part of the QbD Group – has a team of experts in quality assurance and regulatory affairs. Most team members had 10 to 30 years of experience in the In Vitro Diagnostics industry, before joining Qarad. The team does not only fully understand the regulations, but also the different assay technologies.

Qarad is certified for ISO13485 and ISO27001 standards. The nomination for the TOPRA Award in the category Innovation recognizes that we provide practical tools for IVD manufacturers to cope with regulatory requirements. The technical documentation of the first Class C IVD ever certified by a notified body, was entirely compiled by Qarad.