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366 results:
Artificial Intelligence and Medical Devices  
Artificial Intelligence in Medicine More and more medical devices are using artificial intelligence to diagnose patients more precisely and to treat them more effectively. Although a lot of devices  
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Parameterization of software  
Parameterization of Software The parameterization of software - in this context, we can also talk about customizing or configuring software - often leads to discussion, e.g. regarding responsi  
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Free Sales Certificates  
Requesting Certificates of Free Sale Certificate of free sale, export certificate, certificate of marketability, free trade certificate, free sale certificate, free sales certificate. Even the auth  
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Vital physiological processes - decisive for classification  
Vital physiological processes - decisive for classification Both the Medical Device Regulation (MDR) and the Medical Device Directive (MDD) classify medical devices according to whether they diagno  
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Risk Based Approach  
Risk-Based Approach A lot of authorities and regulations talk about a risk-based approach. However, they do not define the term or give any examples. This article will give you an overview of wh  
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Document Control - Document Release  
Document release - is the four-eyes principle necessary? An efficient document release procedure is one of the most important prerequisites for an effective quality management system. This articl  
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Heuristic Evaluation  
Heuristic evaluation of medical devices Heuristic evaluation is a process which usability experts use to assess the usability of products by means of heuristics (explained in more detail below  
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Purchasing controls: Supplier evaluation – supplier selection – supplier audits  
Supplier evaluation – supplier selection – supplier audits The MDR and ISO 13485:2016, just like the FDA, set out clear requirements regarding supplier evaluation, sup  
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Electronic signatures and electronic records: FDA and MDR requirements  
Electronic and digital signatures Electronic signatures and digital signatures should be considered on an equal level to handwritten signatures (‘wet ink’). The requirements that need to be fulfi  
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Periodic Safety Update Report (PSUR) and Post-Market Surveillance Report (PMS Report)  
Periodic Safety Update Report (PSUR) and Post-Market Surveillance Report (PMS Report) The MDR and IVDR require either a “Post-market surveillance report” or a “Periodic safety update report” from m  
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