IVD Development
At Edinburgh Genetics, our expertise in In Vitro Diagnostic (IVD) Medical Device Development is underpinned by an extensive comprehension of disease mechanisms, biomarker discovery, and assay optimisation across diverse methodologies, including immunoassays, biochemical assays, nucleic acid amplification techniques, and next-generation sequencing (NGS).
Quality Management
Our adherence to ISO 13485 underscores our dedication to excellence and safety, guaranteeing that our processes align with the most stringent industry benchmarks. This commitment not only facilitates a seamless interaction with regulatory bodies but also accelerates the approval and market introduction of our devices, ensuring they are swiftly available to healthcare professionals.
Facilitating Regulatory Navigation and Market Introduction
Our team is versed in the intricacies of global regulatory frameworks, ensuring our devices meet the most rigorous standards, including the In Vitro Diagnostic Regulation (IVDR). Our regulatory strategy is built on a foundation of proactive engagement with regulatory bodies, notified bodies and end users. This approach not only ensures our IVD devices are consistently compliant but also streamlines their path to market, thereby facilitating quicker access for healthcare providers and enhancing patient care.
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