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No successful registration!  
No successful registration! We are sorry, the seminar is already fully booked. You are welcome to register for another date, another seminar or contact us at seminare@johner-institut.de.   
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Thank you  
Thank you very much for your registration! You will immediately receive a detailed confirmation by email. The invoice for your booking will follow shortly to your email. If you have not receive  
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Micro Consulting - Ask an Expert  
Micro Consulting: Experts will answer your specific and crucial questions Ask an expert: Competent assistance within 48 hours Have a specific question? We offer quick, direct help - free of  
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Risk Management & ISO 14971  
ISO 14971 and Risk Management The ISO 14971 is the standard for the "Application of Risk Management for Medical Devices". It describes a risk management process to ensure that the risks ar  
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Usability Labs  
Usability Labs In addition to the Johner Institute's own usability labs, we offer cooperation with partner spaces in countries where we do not operate full-time. Our labs offer: Observation r  
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Summative Evaluation / Validation Testing  
Summative Evaluation / Validation Testing In contrast to formative usability tests, summative usability tests take place at the end of development with production-equivalent devices and materials.  
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Stakeholder Requirements Analysis  
Stakeholder Requirements Analysis During context analysis, we interview or observe users in their natural usage context and environment. We first define the user groups and then develop interview g  
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MDCG 2020-6: Clinical Data Requirements for Legacy Devices  
MDCG 2020-6: Clinical Data Requirements for Legacy Devices Currently, manufacturers of legacy devices can keep their devices on the market without demonstrating conformity under Regulation 2017/745  
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Heuristic Evaluation  
Heuristic Evaluation and Expert Review A heuristic evaluation involves evaluation of the user interface according to usability heuristics by usability engineering experts. Evaluations can be perfor  
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Formative Evaluation  
Formative Evaluation Both the FDA and IEC 62366-1 require formative and summative usability evaluations. It is recommended to perform formative usability tests iteratively at different points in de  
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