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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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Glossary for medical device manufacturers  
Glossary for medical device manufacturers A Term Definition Source More information Accessory for a medical device  
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The Team  
The Johner Institute Consulting Team We ourselves are people who, from the heart, are passionate about developing medical software and have years of experience in this field. We have participated i  
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Software Architecture  
Software Architecture (Compliant with IEC 62304) The software architecture is the description of the internal structure of a software system. Typically, the software architecture identifies the compo  
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Usability Validation  
Usability Validation: Compliant with IEC 62366 and FDA The usability validation is a test with objective means, whether the specified users can reach the specified user objectives (intended use) effe  
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EU Data Act: Hand over the data!  
The EU Data Act obliges providers of many devices and services to provide users with extensive data. A danger!  
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Remediation: When things hit the fan  
Remediation is the elimination of non-conformities (e.g., processes, products). It requires a remediation plan. Tips!  
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Design Change: Examples and Requirements  
Design Change: Examples and Requirements A design change is a change in the design of a product. It is important to understand what regulatory implications arise from this and where there may be an  
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Product Liability: Medical Device Manufacturers Pay Attention  
Product Liability: Medical Device Manufacturers Pay Attention! Neither the MPG nor the MDR contain regulations on product liability, i.e., manufacturers’ liability for harm caused by defective devi  
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The Clinical Evaluation Plan  
The Clinical Evaluation Plan is one of the most challenging and error-prone documents. These tips will make your auditors happy!  
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