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366 results:
IEC 60601-1 Essential Performance in Medical Devices  
Essential Performance in Medical Devices IEC 60601-1 describes essential performance as performance necessary to achieve freedom from unacceptable risk. This article aims to explain what the stan  
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EU Declaration of Conformity  
EU Declaration of Conformity The EU declaration of conformity is an important legal document in which the manufacturer declares the conformity of their medical device. In this article you will lear  
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IEC 60601-1-8: 12 steps back to conformity  
IEC 60601-1-8: 12 steps back to conformity The IEC 60601-1-8 is a collateral standard to the IEC 60601-1, the standard containing the general specifications. The IEC 60601-1-8 sets out re  
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IEC 62366-1:2015 new information on the usability standard  
IEC 62366-1:2015 new information on the usability standard The standard on the usability engineering process, IEC 62366-1:2015, has been amended several times since it was published in 2015. Correc  
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Classification: 8 Tips for Precise Pigeonholing  
Classification: 8 Tips for Precise Pigeonholing Medical device manufacturers come across the concept of “classification” in various different contexts: when developing devices and having them autho  
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Virtual Manufacturing / Own-brand Labeling  
Legal Manufacturer Steps to certification The TÜV provides four steps for certification. We would love to support you through this process so that you can complete the steps more quickly and cost-  
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Content Technical Documentation  
Verification and validation plans and results. This includes electrical safety, EMC, and biological safety testing. Clinical evaluation Regulatory documents such as an MDR checklist, declarati  
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Human Factors / Usability (IEC 62366 and FDA)  
About 70% of all software-related FDA recalls are due to lack of usability. As a result, laws in Europe and the U.S. require that you identify and manage the risks posed by your products' lack of us  
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Electrical Safety & IEC 60601  
You can reach us: per Mail:info@johner-institut.de, by phone +49 (0) 7531 94500 20 or per contact form CONTACT US Give us a call, send us an E-Mail or fill out the contact form so we ca  
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Safety and EMC test laboratory  
Safety and EMC test laboratory: Fast, safe and cost-effective to a standard-compliant "test report" Give us a call, send us an email or fill out the contact form so we can understand  
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