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Search results for: Medical Device Regulation (MDR)

MDR Rule 11: Classification Rules for SaMD with their benefits and challenges

Software development for medical devices has become significant with technology growth in recent years. However, improving patient care, diagnosis, and treatment through software as a Medical Device (SaMD) brings challenges, such as requiring specific regulations to ensure patient safety. Here enters MDR Rule 11, a crucial framework establishing Classification Rules for medical software. In this article, you will learn about the benefits and challenges associated with Rule 11, the criteria of MDR classification and the steps of deployment and regulation of SaMD applications.

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Medical Device Regulation (MDR) and its consequences for healthcare software development

Innovating in the healthcare industry means improving people’s lives through technology. But it also means adhering to regulations that ensure the solutions you create are safe for the patients – in many different ways. Medical Device Regulation (MDR) is probably the most important set of rules you need to follow when building a medical app which would be launched on the European market. The term medical app in this article means a medical app, a medical device, according to the MDR. Let’s dive into why it exists, what it means for the health tech sector, and why you should get familiar with it.

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Security of data documentation – electronic health records and patient data

One of the most critical issues concerning the computerization of the healthcare system is data documentation security. The obligation to ensure both physical and electronic health records (EHR) and other types of healthcare data is largely on the medical institutions. In the following text, we’ll look at the conditions they must meet under the law and good practices. We’ll also present the life cycle of documents and suggest what standards should be completed by a software provider if you’re to entrust them with the digitization of your medical facility data.

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Technical & legislative challenges of cloud solutions for healthcare software

The eHealth industry’s growing at a breakneck pace, undoubtedly influenced by the ongoing COVID-19 pandemic and technological advancements, including the use of cloud solutions for healthcare. According to a report compiled by Market Data Forecast, this market is currently valued at $14.8 billion and is expected to grow to $29.5 billion by 2026. This implies a CARG (Compound Annual Growth Rate) of 14.8% for the eHealth sector over the forecast period. What impact do cloud solutions have and will have on the growth of the eHealth sector? What technical and legal challenges connected to using the cloud are there in the healthcare market? Let’s try to answer these questions.

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