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What Manufacturers Need to Know about Legacy  
What Manufacturers Need to Know about Legacy Devices Legislators are continually changing the regulatory framework for medical devices, as we have seen in Europe with EU Regulation 2017/745 (MDR) a  
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Does ISO/IEC TR 29119-6 on software testing help in agile projects too?  
Does ISO/IEC TR 29119-6 on software testing help in agile projects too? ISO/IEC TR 29119-6 aims to help meet the requirements of the ISO 29119 family of standards (in other words the other family m  
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Notified bodies  
Notified Bodies Notified bodies are government accredited, mostly private companies that take over sovereign tasks on behalf of national authorities. Definition: Conformity Assessment Body and Not  
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CE Marking  
CE Mark: What it actually stands for Originally CE stood for Communauté Européenne (European Community) later for Conformité Européenne. With the CE mark a manufacturer expresses conformity  
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Accessories for Medical Devices  
Medical devices accessories have to meet the same regulatory requirements as the medical device. However, there are differences, manufacturers should be aware of.  
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Software as Medical Device  
Software as Medical Device: Definitions and Classification Aids With software as medical device, it differentiates between standalone software and software that is part of a medical device.  C  
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Design History File: What Your DHF should Include  
Design History File: What Your DHF should Include The FDA requires in 21 CFR Part 820.30 a Design History File DHF (these are the "Quality System Regulations"). DHF should not be confused  
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Unannounced Audit  
Unannounced Audits by Notified Bodies Unannounced audits are random sampling checks of the quality management systems by notified bodies with the aim of finding out if medical device manufactur  
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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 6  
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