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New Zealand  
Location New Zealand Johner Institute New Zealand Ltd Adress: 235 High Street Christchurch, 8013 New Zealand Telefon: +64 (03) 423 3460 Mobil: +64 (0) 212 773 791 https  
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AI Medical Devices  
Medical devices with artificial intelligence: get through audits and licensing with confidence Medical devices with artificial intelligence: get through audits and licensing with confidence Neithe  
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Software Documentation (IEC 62304, FDA)  
Software documentation: Pass medical device approval fast and without hassle We help you at minimal cost that your software documentation is 100% IEC 62304 and FDA compliant How we will help you  
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Starter-Kit  
Getting an overview of regulations and standards is a headache for you? We help you from the very beginning.... The Johner Institute Starter Kit Your personal starter kit - request easily! Please  
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Johner Institute North America  
Our mission is to help medical device manufacturers overcome regulatory challenges and bring safe products to market faster. Can we help you with that? Regulatory Intelligence Our cutting-edg  
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IVD Software  
Qualification and classification of IVD software   The qualification and classification of IVD software determine how and how quickly IVD manufacturers can bring their software to market and  
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Regulatory Requirements for Medical Devices with ML  
Regulatory requirements for medical devices with machine learning The incorporation of AI in medical devices has made great strides, for example, in the diagnosis of disease. Manufacturers of dev  
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Risk management in hospitals and at other operators  
Risk management in hospitals and at other operators Laws require risk management in hospitals, especially in order to improve patient safety. Nevertheless, many hospitals find this difficult. T  
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Contact Us  
Contact Us Contact Us Please provide us with the information below, and we’ll connect you with the Johner Institute specialist who can best respond to your questions.  
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In-vitro Diagnostic Device Regulation (IVDR)  
Regulation (EU) 2017/746: In vitro Diagnostic Medical Device Regulation (IVDR)   February 2024  The European In Vitro Diagnostic Medical Device Regulation (IVDR) must be followed by ma  
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