Blog on Clinical research with medical devices​

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ISO14155:2020 as a harmonized standard

What is the harmonized standard?  Last month, we discussed clinical evaluation and clinical investigation, during which we also touched on the ISO14155:2020. This month, we’re going to dive into this even further. The ISO14155:2020 is recognized as an harmonized standard. In accordance with Article 5(1) of the Council Directive, all EU member states should aim to follow certain

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Clinical evaluation vs clinical investigation

Clinical Evaluation vs. Clinical Investigation

You know by now what a medical device is; you’ve seen them, you’ve read about them, they stand to be one of the greatest medical inventions of our time. But, how does it come to life? Which processes are involved when placing a medical device on the market? A medical device follows a detailed set

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