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366 results:
Why you need a QM system  
Why you need a QM system The quality management system is important If you have a lean, precise and standards-compliant QM system, you will survive audits and inspections without stress, ful  
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Why the Johner Institute?  
Why the Johner Institute? With us, you will flourish in an atmosphere of creativity, trust, mutual support and the pursuit of excellence. Rigid, hierarchical structures, frustrating supervisor de  
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User Interface (UI) Design  
User Interface (UI) Design We design wireframes, create prototypes and design proposals for software and hardware UIs. We offer a variety of services to aid your product design, including: Crea  
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Usability & IEC 62366  
Here you will find information on the usability / human factors engineering of medical devices and regulatory requirements such as FDA and IEC 62366 Usability Testing in Times of Corona Manufacturer  
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The Company  
Certificates To meet our own quality requirements, we have established a QM system and have been certified according to ISO 13485:2016 since 2018. LEARN MORE The Company Our Values We see our  
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Software Requirements  
Documenting the software requirements compliant with IEC 62304 The IEC 62304 demands that you specify the software requirements in section 5.2. This article shows you how you can not only conform to  
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Services  
Our Services Our Services Regulatory Affairs Do you want to market your medical device worldwide (e.g. in Europe, the USA, China etc.) quickly, safely and at minimum cost? Then the Johner Institu  
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Regulatory Radar  
Regulatory Radar: So that you don't miss any regulations Improve compliance with less effort and lower costs For Quality Management Officers, Quality Managers and Regulatory Affairs Managers Don  
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QMS Compliance  
Navigate the audit quickly and safely with a lean QM system Get in touch Get in touch with us so we can design your lean QM system! Get in touch Act as your legal manufacturer & provide our  
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Prof. Dr. Johner  
Prof. Dr. Christian Johner Christian Johner is passionate about software development, medicine, quality management and teaching. His missions are to encourage those, who work in combined field of  
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