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Sources Of Real World Evidence

There are multiple ways to generate Real World Evidence (RWE). This article outlines some of the different methods available for collecting real-world data and producing RWE. Unfortunately, the method chosen by medical device manufacturers often isn’t the best one for their needs.

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The New EU MDR Compliance Challenge

May 2021 marks the end of the transition period from the old Medical Device Directive (MDD) to the new Medical Device Regulations (MDR) 2017/745. From this date, the MDR will be in full effect and EU-based medical device manufacturers will be required to provide updated technical documentation.

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A proposal to delay the EU MDR gets approved

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Bridging the gap — ensuring that clinical investigations work in practice

Well-designed clinical investigations are at the core of meeting medical device regulatory requirements under the MDR. More than ever before, the MDR requires manufacturers to have a detailed understanding of how to produce high-quality clinical evidence to support their products.

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Software As A Medical Device

Unless you have spent time working with medical device legislation in the past, the idea that software could be a medical device may be rather unexpected — a medical device is perhaps more traditionally viewed as a hardware product. Nonetheless, it is the case

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EU MDR Compliance Guide - Mantra Systems

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Real World Evidence For Medical Devices

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Learn About PMS Post Market Surveillance

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Post-Market Clinical Follow-up (PMCF) is the process of proactively and continually collecting and evaluating clinical data on the safety and performance of a CE-marked medical device throughout its entire lifetime.

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