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366 results:
Risk mitigation through information?  
Risk mitigation through information? Whether risk mitigation through information is permitted regularly leads to discussions. The answer to this question is important because it determines the conf  
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Differences between the IVDR and IVDD  
Differences between the IVDR and IVDD Since May 25, 2017, the In Vitro Diagnostic Medical Device Regulation (IVDR) has been in force, which has now replaced the previous IVD Directive (98/79/EC, IV  
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Software Testing  
Software Testing The software testing, in addition to structural measures (for example, work on the software development processes, methods and the use of tools), is an essential part of software qual  
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The 7 most common risk management errors  
The 7 most common risk management errors This article identifies the seven most common risk management errors that Johner Institute and its auditors encounter most often. It also offers advice on h  
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Medical Device Advertising in Germany and the EU – What is Allowed and What Isn’t  
Medical device advertising is generally permitted in Europe, but there are some specific requirements that have to be taken into account. What the UWG, HWG, MDR and IVDR say.  
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EU HTA Regulation 2021/2282 – What the Harmonized Health Technology Assessment Will Bring  
In the HTA Regulation, the EU provides the framework for Europe-wide HTAs. Find out how this affects you as a manufacturer.  
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Digital Transformation  
Digital Transformation Digital technologies are fundamentally changing the medical device industry. But not all manufacturers are aware that, to keep up, they don’t just have to develop devices tha  
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Medical Device Sustainability  
Medical Device Sustainability – in the EU and Germany Sustainability is ubiquitous these days. Nevertheless, it seems to be taking hold more slowly in the medical technology sector than in other se  
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Design Thinking: More Usability and Better Medical Devices  
Design thinking is an approach to innovation that focuses on people’s needs. Learn how it can help in medtech.  
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“James Elliott” and “Global Garden” Impact of EU Case Law on Standard Harmonization  
“James Elliott” and “Global Garden”: Impact of EU Case Law on Standard Harmonization Harmonization of standards in the EU has been slow-going for several years. Medical device manufacturers are cur  
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