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Coding Guidelines  
Coding for Medical Devices Software Thursday, February 12, 2015 by Christian Johner Medical device manufacturers ask me regularly in my free audit consultation which coding guidelines we should obser  
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Safety Classes versus Level of Concern  
Software Safety Classes (IEC 62304) versus Levels of Concern (FDA) Both, European and US regulations, distinguish three different categories of medical device software, the software safety classes  
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SOUP and OTS  
SOUP – Software of Unknown Provenance SOUP is an acronym for "Software of Unknown Provenance". The IEC 62304 defines a SOUP as follows: Definition: SOUP „SOFTWARE ITEM that is already develo  
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Mobile Medical Apps  
Mobile Medical Apps Medical Apps, also referred to as Mobile Medical Apps, are applications for mobile devices such as smartphones or tablets that support medical professionals or patients in the di  
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Risk Analysis  
Risk Analysis Risk analysis is  a search of hazards and an assessment  of possibilities and severities resulting damages. Typical process of risk analysis The aim of risk analysis is to id  
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EUDAMED: European Databank on Medical Devices  
EUDAMED: European Database on Medical Devices EUDAMED is the European database for medical devices. However, it is not only used to manage medical devices. The Medical Device Regulation (MDR) rel  
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Common Specifications  
Common Specifications - Competing with Standards? Both the MDR and IVDR introduce the concept of Common Specifications. MDR and IVDR define common specifications as follows: Definition: Com  
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MDR Rule 11: The Classification Nightmare  
MDR's classification rule 11 is a nightmare: It will be a major issue for manufacturers of medical device software. Read what's new and why the EU commission needs to act.  
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Life Cycle Risk Management  
Alignment of Development and Risk Management Process How you can fulfill the requirements of ISO 14971, ISO 13485, IEC 62304 and IEC 60601-1 in a process The most relevant standards for the de  
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Computerized System Validation CSV  
Computerized System Validation CSV We frequently get asked, "Do you also offer Computerized Systems Validation?" One of the reasons for the interest is certainly: Authorities and notified bodies in  
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