1.0Clinipower Finland Oyhttps://www.clinipower.fi/en/Sylvia Syvänenhttps://www.clinipower.fi/en/author/sylvia/Five Pitfalls in MDR Clinical Evaluation - Clinipower Finland Oyrich600338<blockquote class="wp-embedded-content" data-secret="xTm2UYP0rP"><a href="https://www.clinipower.fi/en/five-pitfalls-in-mdr-clinical-evaluation/">Five Pitfalls in MDR Clinical Evaluation</a></blockquote><iframe sandbox="allow-scripts" security="restricted" src="https://www.clinipower.fi/en/five-pitfalls-in-mdr-clinical-evaluation/embed/#?secret=xTm2UYP0rP" width="600" height="338" title="“Five Pitfalls in MDR Clinical Evaluation” — Clinipower Finland Oy" data-secret="xTm2UYP0rP" frameborder="0" marginwidth="0" marginheight="0" scrolling="no" class="wp-embedded-content"></iframe><script>
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https://www.clinipower.fi/wp-content/uploads/2022/03/anejamonitori-1200px-72dpi.jpeg1200800Placing medical devices on the market and keeping them there is now about much more than technical documentation and a quality system. The EU Medical Device Regulation (MDR) has shifted the emphasis strongly toward clinical evaluation. Manufacturers must continuously demonstrate that their device is safe, achieves its intended performance, delivers clinical benefit, and has an