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“James Elliott” and “Global Garden” Impact of EU Case Law on Standard Harmonization  
“James Elliott” and “Global Garden”: Impact of EU Case Law on Standard Harmonization Harmonization of standards in the EU has been slow-going for several years. Medical device manufacturers are…  
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Medical devices in Turkey: Regulatory requirements  
Medical devices in Turkey: Regulatory requirements While not an EU Member State, Turkey has aligned its regulatory framework for medical device manufacturers with that of the European Union. …  
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Regulations as Code: The End of Regulations as We know it  
5. Conclusion, summary a) This is not a pipe dream Regulation as code, or the transformation of regulations into algorithms, may sound like a pipe dream. But implementation has already started.…  
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Functional safety for medical devices  
Functional safety for medical devices Medical Electrical Equipment must meet the legal requirements for safety and performance. A frequently used term in the context of safety and performance…  
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ISO 17664 - Processing of Medical Devices  
ISO 17664 - Processing of Medical Devices The title of EN ISO 17664-1:2021 is “Processing of health care products — Information to be provided by the medical device manufacturer for…  
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Use Scenario - User Story - User Task: Finally understandable  
Use Scenario - User Story - User Task: Finally understandable IEC 62366-1 uses the concept of (hazard-related) use scenario. The FDA uses the concept of critical (user) tasks. In development,…  
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Risk management report: There are options  
Risk management report: There are options Laws and standards require organizations to prepare a risk management report. Notified bodies and authorities examine these reports intensively because…  
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eQMS  
JCeQMS - for those who want to revolutionize their quality management  Save valuable time and money building and maintaining your quality management system.  JCeQMS is a cloud-based,…  
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Digital Transformation  
The future has already begun Digital transformation is not a dream of the future. The Johner Institute is already supporting medical device manufacturers, authorities and notified bodies: …  
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Electronic instructions for use for medical devices (EU law)  
Electronic instructions for use for medical devices (EU law) EU Regulation 2017/745 (MDR) establishes the general requirements for instructions for use (IFU). Whether they can also be provided in…  
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