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      Norifumi Ninokata

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      Health claims are statements made on food or supplement labels that describe the relationship between a food component and improved health or reduced risk of di

      How to get health claims approved in the eu/us

      Andmerobot
      Health claims are statements made on food or supplement labels that describe the relationship between a food component and improved health or reduced risk of disease. These claims are heavily regulated to ensure consumer protection and scientific accuracy. The European Union and the United States have distinct regulatory frameworks for health claims. In the EU, the European Food Safety Authority (EFSA) is responsible for evaluating the scientific evidence behind health claims, while in the US, the Food and Drug Administration (FDA) oversees the approval process. Understanding these

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      MEDFILES OÜ / Andmerobot

      Navigating clinical trials for medical devices

      Clinical trials are a critical phase in the development of medical devices, ensuring that new products are safe and effective for patient use. These trials prov
      ssb.ee
      Clinical trials are a critical phase in the development of medical devices, ensuring that new products are safe and effective for patient use. These trials provide the scientific evidence necessary to satisfy regulatory requirements and gain market approval. Unlike pharmaceutical trials, medical device trials often involve additional complexities such as device-operator interactions, varying patient anatomies, and the iterative nature of device development. Regulatory Framework for Medical Device Trials Regulatory bodies such as the FDA in the United States, EMA in Europe, and others

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