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Product Liability: Medical Device Manufacturers Pay Attention  
Product Liability: Medical Device Manufacturers Pay Attention! Neither the MPG nor the MDR contain regulations on product liability, i.e., manufacturers’ liability for harm caused by defective…  
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The Clinical Evaluation Plan  
The Clinical Evaluation Plan is one of the most challenging and error-prone documents. These tips will make your auditors happy!  
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The end of 21 CFR part 820?  
QMSR: The end of 21 CFR part 820? In 21 CFR part 820, the FDA formulates the requirements for the quality management systems of medical device manufacturers, among others. Thus, 21 CFR part 820…  
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MDCG 2020-5: The End of the Equivalence Route for Clinical Evaluations?  
MDCG 2020-5: The End of the Equivalence Route for Clinical Evaluations? The document MDCG 2020-5 (“Clinical Evaluation – Equivalence”) increases the requirements for the equivalence of medical…  
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Clinical endpoints: Why they are important  
Clinical endpoints: Why they are important When notified bodies identify discrepancies in clinical evaluations, in many cases, these relate to the clinical endpoints. It is, therefore, essential…  
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Clinical Data for Medical Devices  
Clinical Data for Medical Devices Medical device manufacturers are obliged to systematically collect and evaluate clinical data, both before and after the approval of their products. The EU…  
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Clinical evidence: How to prove it  
Clinical evidence: How to prove it Only through clinical evidence - real evidence - can manufacturers prove their medical devices' safety, performance, and benefit. But when is proof valid enough?…  
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Pass an FDA inspection with confidence  
Pass an FDA inspection with confidence For many manufacturers of medical devices, an FDA inspection is associated with great stress. Many companies are aware of the possible consequences, such…  
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ISO 10993-17: What the standard has changed and now requires from manufacturers  
ISO 10993-17: What the standard has changed and now requires from manufacturers   The ISO 10993-17 standard is part of the ISO 10993 series of standards on biocompatibility. ISO 10993-17…  
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Transitional provisions of the IVDR  
Transitional provisions of the IVDR Attention! We have revised this article for you and taken into account the proposal to amend the transition periods of the IVDR published on the January…  
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