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Clinical Investigation  
Insurance for Clinical Investigations Manufacturers who conduct clinical investigations of their medical devices must take out insurance. This requirement is established by the MDR and IVDR (among  
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Validation of Machine Learning Libraries  
Validation of Machine Learning Libraries Tuesday, February 25, 2020 More and more manufacturers are using machine learning libraries, such as scikit-learn, Tensorflow and Keras, in their devices  
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Digital Health Applications Ordinance (DiGAV, Digitale-Gesundheitsanwendungen-Verordnung): What Manufacturers Should Know  
Digital Health Applications Ordinance (DiGAV, Digitale-Gesundheitsanwendungen-Verordnung): What Manufacturers Should Know Tuesday, April 21, 2020 On April 17, 2020, the German Federal Ministry of  
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How You Can Meet the Data Security and Protection Requirements for Digital Health Applications  
How You Can Meet the Data Security and Protection Requirements for Digital Health Applications The data security and data protection requirements for DIGA (digital health applications) go far  
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Post-Market Surveillance Plan: Complying with the Requirements of ISO TR 20416  
Post-Market Surveillance Plan: Complying with the Requirements of ISO TR 20416 With the post-market surveillance plan, manufacturers are trying to achieve two (potentially) contradictory goals. On  
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Why the ClinicalTrials Search Mask Could Cost You Hundreds of Thousands of Euros  
Why the ClinicalTrials Search Mask Could Cost You Hundreds of Thousands of Euros The ClinicalTrials.gov search function provides both incomplete and too many results. This can have fatal consequenc  
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State of the Art: It’s Worse Than You Think  
State of the Art: It’s Worse Than You Think Auditors and regulatory authorities regularly discuss what the state of the art is with medical device manufacturers. These discussions are intensifying  
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The Medical Device File: What You Don’t Have to Include in This File  
The Medical Device File: What You Don’t Have to Include in This File ISO 13485 requires a medical device file for each medical device type or medical device family. A lot of many manufacturers thin  
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ISO 27001: IT Security Management for all Medical Device Manufacturers?  
ISO 27001: IT Security Management for all Medical Device Manufacturers? ISO 27001 and information security management systems (ISMSs) are becoming increasingly common topics of debate during ISO 13  
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Computer-Based Modeling & Simulation: Not Just a Tool for Quicker Authorizations  
Computer-Based Modeling & Simulation: Not Just a Tool for Quicker Product Approval Computer-based modeling and simulation are increasingly important during the development and authorization of  
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