Accelerate your market entry with our integrated IVDR and WHO strategy, ensuring compliance while minimizing costs and sample size for diagnostic tests.
A pioneering in vitro diagnostics (IVD) company focused on point-of-care molecular testing. Known for its diverse portfolio, the company develops rapid diagnostic tools that support real-time, accurate decision-making in clinical practice. From infectious diseases to genetic disorders and oncology, their solutions are designed to improve patient outcomes across a range of healthcare settings.
The client aimed to launch a Class D diagnostic test-suitable for professional, near-patient, and self-testing - in the European market under IVDR while simultaneously pursuing WHO prequalification.
Navigating these two regulatory frameworks posed significant challenges around complexity, timelines, and sample volume requirements.
To tackle this, we designed an integrated strategy that combined IVDR and WHO requirements to avoid duplication and minimize the total sample size.
Our team managed four tailored studies:
Serving as the client’s legal representative, we facilitated smooth ethical and regulatory approvals. From study setup to site coordination and ongoing communication with authorities, we provided full project management to keep everything on track.
This first-time-right strategy enabled the client to meet both IVDR and WHO requirements simultaneously, reducing sample needs and accelerating timelines.
The efficient approach saved costs and cut time to market, earning praise for our expertise and practical solutions. This success also paved the way for ongoing collaboration on multiple additional products.
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