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Quality management system support  
Quality management system support Nothing unnecessary We create a lean QM manual. This not only means less work for us, but also for you both to understand and develop the system and to introduc  
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Quality management representative: Challanges and Support  
External Quality Management Representative External Quality Management Representative Challenges There are several challenges companies face with respect to quality management representatives:&nb  
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Medical Device Software & IEC 62304  
Medical Device Software, IEC 62304 and FDA requirements In this section we cover all aspects related to medical device software. You will find hints on how to effectively and efficiently fulfill the  
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Classification of Medical Devices according to MDD  
Definition: Medical Device „Any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human b  
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Page not found  
Please feel free to contact us! We are looking forward to hear from you! Contact us! Ooops, we lost a Page!? Some people speak of a 404 error… We are sorry! The page you are looking fo  
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Content: What the e-learning program includes  
Content of the E-Learning Programm Learn how to market your medical device The training videos open the door to a quality approved auditor knowledge. These materials are not only used by hundreds  
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Technical Documentation  
Technical Documentation Medical device manufacturers have to prove compliance of their products to US and European authorities (FDA respectively notified bodies). Get in touch Get In Touch Get  
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Checklist Software Requirements Specification  
The SSRS checklist prepares to for FDA submissions and CE-approvals. Evaluate whether your SRS is FDA and IEC 62304 compliant  
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Conformity Assessment Procedure according to MDR  
Conformity Assessment Procedures according to MDR Medical device manufacturers have to follow conformity assessment procedures before placing products on the market. With these conformity assessmen  
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