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106 results:
Safety and EMC test laboratory  
Safety and EMC test laboratory: Fast, safe and cost-effective to a standard-compliant "test report" We make sure that the electrical safety and electromagnetic compatibility of your medical…  
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Process automation  
Process automation and outsourcing Outsource annoying, time-consuming and repetitive, yet legally mandatory activities to us. How we help you We take recurrent, time-consuming tasks off your…  
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Market Access US & International  
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…  
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IVD Admission Strategy  
Pending new approval for your invitro diagnostic medical device (IVD) Are you sure your approval strategy will get you through the audit in 2022? Many IVD manufacturers are not aware of the…  
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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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Performance evaluation of IVDs  
Performance evaluation of IVDs The performance evaluation is a central process that accompanies the entire life cycle of an in-vitro diagnostic medical device (IVD) and has numerous interfaces to…  
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Human Factors Research  
Human Factors / Usability Engineering and Usability Testing in Europe and the US Create IEC 62366-1 and FDA-compliant usability files in no time at all. Pass FDA approval with 100%…  
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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…  
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FDA relevant documents  
Get through 510(k) approval and FDA inspection without any problems What we can do for you Many people thing FDA reviews are strict and formal. Violating the requirements of the US authorities…  
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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, …  
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