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EU MDR is undoubtedly a fantastic way of upgrading the medical device market quality, but the process is anything but easy. With the slow but steady transfer of MDD to MDR, various aspects of requirements regarding medical device regulation are changing every day. With that comes new regulations and, with that, new documents for us [...]

Move over, Dr House, there's a new diagnostician in town, and it's not human! Thanks to the power of AI, medical devices are becoming smarter than ever, analyzing data faster than ever and creating regulatory headaches as they go.   From detecting irregular heartbeats to identifying suspicious moles, these devices are the ultimate sidekick for [...]

Medical writers make up much of the medical device regulatory industry. In fact, they are one of the largest contributors behind the thousands of devices that get conformity approval each year. However, good medical writers are hard to come by. The thing is, you need a very specific set of skills to become a [...]

You want to sell your device in the European Union and start the CE marking process. But after reviewing the MDR and the guidance documentation, you begin to doubt the CE mark process.   Are clinical evaluations before or after product development? Do you need post-market surveillance or post-market clinical follow-up? And what even is [...]

Implementing the MDR or Medical Device Regulation will bring significant changes to the process of Clinical Evaluation and subsequent post-market compliance requirements. This, of course, is a significant concern for medical device manufacturers in the EU. Some changes may be relatively minor, such as the change in terminology from Essential Requirements to General Safety and Performance [...]