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366 results:
Threat Modeling – An Introduction  
Threat Modeling – An Introduction Threat modeling is a “mandatory” topic for all manufacturers of medical devices that contain or are software. This is because threat modeling is a structured proce  
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Class-1-Software  
Class I software Practical guidance based on the experience of the Johner Institute, Oliver Hilgers and Stefan Bolleininger  The discussion about class I software continues to rage. Thi  
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Digitalization of notified bodies  
Digitalization of notified bodies Digitalization of notified bodies will transform the medical device ecosystem over the next few years. This article describes the impact of this digitalization  
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Maintenance and service of medical devices  
Maintenance and service of medical devices The terms maintenance, preventive maintenance, refurbishment, inspection, service, and safety inspections are not synonymous. But they all refer to activi  
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Regulatory Intelligence - a core task of Regulatory Affairs?  
Regulatory Intelligence - a core task of Regulatory Affairs? Many companies consider regulatory intelligence so important that they create their own roles and departments for it. This article cla  
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Develop software components compliant with IEC 62304 and FDA  
Develop software components compliant with IEC 62304 and FDA Medical software manufacturers must meet the statutory requirements for software components in order to "approve" their devices. This  
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Development process: Lean and compliant with standards  
Development process: Lean and compliant with standards Laws and standards formulate requirements on how medical device manufacturers must define and document development processes. Notified bodie  
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PFAS ban: You must act immediately!  
PFAS ban: You must act immediately! With PFAS, the EU plans to ban an entire class of chemicals. In doing so, it is not only threatening the supply of medical devices but also the competitiveness o  
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RIMS: Future or anchoring in the past?  
RIMS: Future or anchoring in the past? Medical device manufacturers have high expectations of Regulatory Information Management Systems (RIMS). The costs and efforts involved are immense and usuall  
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MDCG 2023-4 on combinations of MDSW and hardware  
MDCG 2023-4 on combinations of MDSW and hardware MDCG published guideline MDCG 2023-4 in October 2023 entitled "Medical Device Software (MDSW) - Hardware combinations - Guidance on MDSW intended  
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