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EU Battery Regulation: What medical device manufacturers need to know  
EU Battery Regulation: What medical device manufacturers need to know The EU plans to replace the existing Directive 2006/66/EC with the new EU Regulation on batteries and waste batteries ("Battery  
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The Clinical Evaluation Literature Search: 6 Tips to Save You Time and Stress  
The Clinical Evaluation Literature Search: 6 Tips to Save You Time and Stress The literature search is a key part of the clinical evaluation. It usually involves numerous hours of work. This articl  
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Clinical investigations be avoided with artificial intelligence?  
When can clinical investigations be avoided for devices with artificial intelligence? For manufacturers, the answer to whether and when clinical investigations are necessary when using artificial  
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Medicinal product or (substance-based) medical device?  
Medicinal product or (substance-based) medical device? The classification of whether a device is a medicinal product or a substance-based medical device has far-reaching regulatory consequences.  
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Johner Medical  
Johner Medical GmbH The Johner Medical GmbH was founded in December 2019 as a 100% subsidiary of Johner Institut GmbH. Johner Medical takes over regulatory roles for you required by the MDD, MDR, I  
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General Terms and Conditions  
Terms and Conditions 1. Acceptance of Terms of Use Welcome to the website of Johner Institute North America Inc (from now on referred to as the "Johner Institute"). These Terms of Use govern your  
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Johner Institute's Medical Device University  
Level up your medical device skills, grow your career and get your medical device to market faster! Contact Us Self-Assessments and Course Completion Certificates. A turnkey Quality System, co  
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Our Mission  
Our Mission Our Mission What drives us: Our Mission 1. Objective: help companies to develop safe medical products without developing quality management overhead Fewer unsafe medical devices: Alm  
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Sampling Kits from a Regulatory Perspective  
Sampling Kits from a Regulatory Perspective The term "sampling kit" is not defined by the IVDR or any other regulation. Nevertheless, there are (indirect) regulatory requirements that IVD manufactu  
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Laboratory Developed Tests LDT  
Laboratory Developed Tests LDT Laboratory Developed Tests (LDT) are included among in vitro diagnostic tests. However, do the same regulatory requirements apply to these LDTs as, for example, to th  
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