In-Vitro Diagnostic Devices

In-Vitro diagnostic devices (IVDs) play a critical role in the healthcare solution. They allow healthcare providers and patients to efficiently and accurately detect diseases, conditions, or infections. Yet, meeting requirements for IVDs can be difficult, as the approach to IVD regulation varies by market. In some markets, they are regulated as medical devices; in others, manufacturers must meet IVD-specific requirements.

Our team of compliance experts has experience navigating IVD regulations in major markets, including the US, Europe, Latin America, and Asia. We can assist with even the most complex market-entry requirements, from drafting your clinical evaluation report (CER) to designing a global regulatory strategy that leverages your existing approvals.