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Medical apps under the new European MDR

Worldwide 1 out of every 3 internet users currently monitors their health or fitness using an app. This was shown in a recent survey by market researcher GfK. Millions of health-related apps are downloaded every year, and this is expected to be in the billions in 2017. Most of these apps are consumer products being used to monitor health and fitness data for general wellness purposes. Following consumers, healthcare professionals have started adopting the use of apps and more and more apps are being developed specifically for medical purposes. This...

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Notified bodies under pressure

After our recent posts on the proposed Medical Device Regulation (MDR) and MEDDEV 2.7/1 rev. 4, it is interesting to shift our perspective, aiming to get a sense of the potential impact of the new regulatory framework for the medical...

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The post-market world of Class I devices – PMS and PMCF

Post-market surveillance (PMS) and post-market clinical follow-up (PMCF) studies are both an integral part of the upcoming European Medical Device Regulation (MDR), nicely aligned with the requirement to evaluate your medical device thorough the life-cycle of the product. A basic...

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Regulatory
Pre Market

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