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110 results:
Human Factors / Usability (IEC 62366 and FDA)  
Challenges About 70% of all software-related FDA recalls are due to lack of usability. As a result, laws in Europe and the U.S. require that you identify and manage the risks posed by your…  
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Electrical Safety & IEC 60601  
IEC 60601-compliant documentation: Electrical safety, EMC, basic safety We ensure that you develop your product quickly and in compliance with the requirements of the IEC 60601 family and pass…  
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Product Test / Evaluation  
Product test Biocompatibility test The Johner Institute helps you fulfill your legal obligation: to prove that your products are biocompatible and compliant with the relevant regulatory…  
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Biological safety  
Biocompatibility compliant with ISO 10993 Prove the biocompatibility of medical devices quickly, inexpensively and without animal testing The Johner Institute helps you fulfill your legal…  
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Computer System Validation: Avoid trouble!  
Computer System Validation: Avoid trouble with the FDA and the auditor Validation of computer systems is required by law and is checked during FDA inspections and QM audits. We will help you to…  
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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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