Explore our white paper on the clinical testing requirements for medical devices and IVDs under the EU MDR and IVDR. This resource outlines how to design ethical, scientifically sound studies that demonstrate safety and performance in line with GCP and ISO standards. Whether you’re planning pilot, pivotal, or post-market studies, this guide helps manufacturers and regulatory professionals navigate the key steps for EU compliance.
Read the full white paper for expert insights into the clinical pathway under MDR and IVDR.
If you require any further information, contact us at: [email protected]
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