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Agile Software Development  
Agile Software Development for Medical Devices  Many medical device manufacturers are in favor of agile software development. However, they confuse SCRUM with a process model and are not fully…  
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Regulatory requirements for code reviews  
Code Review Tuesday, April 14th, 2015 by Christian Johner We understand the term code review as the checking of the non-compiled source code by other people, for example in the context of…  
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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…  
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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…  
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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…  
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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…  
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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)…  
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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:…  
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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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