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366 results:
Special authorizations for medical devices: Last resort for manufacturers?  
Special authorizations for medical devices: Last resort for manufacturers? Special authorizations are a concept of the MDR (Article 59). In this way, the legislator wants to create a possibility to  
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FDA: The 510(k) clearance (Premarket Notification)  
FDA: The 510(k) clearance (Premarket Notification) 510(k) clearance is the primary procedure for obtaining marketing clearance in the United States. It is also referred to as Premarket Notification  
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Predicate device & substantial equivalence  
Predicate device & substantial equivalence The term “predicate device” most often comes up in the context of FDA 510(k) clearances. However, the FDA does not define this term. It does, howeve  
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FDA Human Factors Guidances  
FDA Human Factors Guidances The FDA describes its requirements for human factors engineering in two documents: 1. Applying Human Factors and Usability Engineering to Medical Devices (Feb 201  
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The EU Regulates Medical Laboratories – Are Laboratory Developed Tests Still Allowed?  
The EU Regulates Medical Laboratories – Are Laboratory Developed Tests Still Allowed? This article will help you ensure that you will still be able to offer in-house IVD (also called laboratory dev  
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Cytotoxicity Testing According to EN ISO 10993-5: Avoiding Pitfalls When Choosing a Laboratory  
Cytotoxicity Testing According to EN ISO 10993-5: Avoiding Pitfalls When Choosing a Laboratory Cytotoxicity testing can be used to test a sample to determine how much it can damage, or even cause t  
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Instructions for Use for Medical Devices and IVDs in the EU  
Instructions for Use for Medical Devices and IVDs in the EU Poor instructions for use are a common cause of use errors that can result in harm to patients and users. Furthermore, instructions for u  
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ISO 10993 and Biocompatibility - Material Certificates Are Not Enough!  
ISO 10993 and Biocompatibility - Material Certificates Are Not Enough! Regulations such as the MDR require proof of the biocompatibility of all materials that come, directly or indirectly, into conta  
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EN ISO 18562: Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications  
EN ISO 18562: Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications The title of the EN ISO 18562 family of standards is “Biocompatibility evaluation of breathing gas pat  
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Biocompatibility  
ISO 17664 - Processing of Medical Devices The title of DIN EN ISO 17664:2018 is “Processing of health care products — Information to be provided by the medical device manufactur  
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