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Medical Device Regulation MDR  
The Medical Device Regulation MDR replaces the European medical device directives (MDD and AIMD). Learn about the new requirements and download the checklist.  
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Main Operating Functions  
Main Operating Functions Main operating function: What the IEC 62366 doesn’t define I have updated the article on the main operating functions (eg taking the definition of the next edition of IEC…  
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Update 14971:2012  
EN ISO 14971:2012 and the Z-annexes EN ISO 14971: 2012: What has been changed to the standard Virtually overnight, namely from 31.08.2012 to 01.09.2012 the ISO 14971: 2012 was published without a…  
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System Architecture  
System Architecture for Medical Devices The System Architecture describes how a (medical) product is composed of components and how the components are related to each other via interfaces. In…  
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Verification versus Validation  
Verification and validation: difference and definitions What is the difference between verification and validation, and how are these terms defined? Even standards and laws use the terms…  
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Harm and Severity  
Harm and Severity Severity of damage in accordance to ISO 14971 The ISO 14971, the standard for risk management for medical devices, defines the term severity (damage) as a "measure of the…  
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Hazard and Hazardous Situation  
Hazard and Hazardous Situation Even though the ISO 14971 defines the terms hazard and hazardous situation, it is still often not so easy for medical products manufacturers to differentiate these two…  
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Risk Acceptance  
Risk Assessment, Risk Acceptance Matrix Each medical device comes with risks. Manufacturers must determine which risks they deem acceptable and which unacceptable. This is usually expressed in the…  
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Risk Mitigation  
Risk Control and Risk Minimization Risk Minimization: General Requirements For medical devices, the benefits must outweigh the risks, i.e. the risks must be controlled. If a manufacturer provides…  
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Software Specifics  
Software Specifics Software risk management are either the risk management activities that medical device manufacturers need carry out for standalone software or the part of the risk management…  
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