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Regulatory affairs: support for the international approval of medical devices  
Regulatory affairs: support for the international approval of medical devices Would you like to bring your medical products to market worldwide (in Europe, the USA, China, etc.) quickly, safely and  
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Thank you, we have received your inquiry  
Thank you, we have received your inquiry! We will also send you an email to confirm that we have received your inquiry. We will very soon get back to you, this means even today or latest in the e  
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User Interface (UI) Design (Design Discovery)  
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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Levels of User Interface Design  
User Interface Design (higher-level menu) We create wireframes and prototypes, interaction and design proposals while considering heuristic design principles We identify suitable methods to sup  
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The clinical evaluation in the MDR  
Safely approve your medical device with MDR-compliant clinical evaluation We help you to meet the complex clinical evaluation requirements of the MDR for your medical device - even the Post-Market  
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Clinical Evaluation of Medical Products  
Clinical Evaluation of Medical Products Medical device manufacturers need to subject their products to a clinical evaluation. This article briefly describes the objectives of the clinical evaluat  
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Articles  
These articles explain how to navigate the medical device approval processes in particular in Europe ("CE-Marking") and the US (FDA).   
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Medical Electrical Equipment & IEC 60601  
Multiple socket-outlets on medical devices Naturally, multiple socket-outlets are needed for medical devices in daily practice as well. However, a lot of people are unaware of the regulatory conseq  
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International  
International Medical Device Authorizations: 5 Steps to New Markets A lot of medical device manufacturers see the international authorization of their device as a potential hazard: the opportunitie  
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Market Access Europe  
Product approval Europe A wisely chosen regulatory strategy helps to get the product through "approval" and thus onto the market with minimal costs and as quickly as possible. The Johner Institute  
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