Bringing an in vitro diagnostic (IVD) to market is a complex process that goes far beyond innovation. From early feasibility studies to regulatory approval, every step requires careful …

Sep 13, 2024 · A comprehensive guide to in vitro diagnostic (IVD) devices, explaining the design, development, and manufacture of these products, applicable regulations, and how they differ …

Guide, you will have a better understanding of how to develop and offer a test as an IVD. Specific topics that will be described include: Why IVDs are regulated as a medical device by FDA. …

Dec 20, 2024 · An overview of how the FDA regulates in vitro diagnostic products (IVD). Manufacturers can find detailed information about complying with the Federal, Food, Drug and …

Feb 28, 2025 · Key development phases include concept generation, feasibility assessment, design and development, validation, and regulatory approval. Each step requires rigorous …

As a result, our R&D team, along with our teams in manufacturing, quality assurance and regulatory, have extensive experience in all phases of IVD product development, starting from …

Essential stages and key considerations in IVD manufacturing, with a high-level map from initial assay concept to post-market surveillance.

Our team of experts manages the entire assay development process, from proof of concept to final product. We deliver high-quality IVD tests that meet client needs and comply with ISO …

In this course, learn the requirements for moving an IVD product from concept to regulatory approval and market launch.

Aug 2, 2025 · FIND divides the product development of an IVD in 6 phases and requires a review at the end of each phase before moving to the next one. Exploration of new biomarkers, …