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110 results:
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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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…  
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World Medical Device Summit  
World Medical Device Summit 2022 World Medical Device Summit 2022 The place where thought leaders come to get inspired The “Why” a) Situation Public healthcare systems are under increasing…  
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In-Country Representation  
Independent Regulatory Representation for Medical Device Companies Authorized Representative for EU, US, CH, UK and NZ Medical device regulations in most countries require foreign…  
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Digital Transformation  
Digital Transformation: The Disruption of Your Regulatory Affairs Processes The solution to the biggest problems: agonizingly long approval times, dull diligence and a worsening skills…  
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IT-Security  
Penetration tests for medical products and applications With targeted penetration tests (pentests), our IT security experts carry out cyber attacks on your software products (e.g. medical…  
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