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Ronen E
21st October 2017 02:03 AM
Harmonized Standards on Medical Device IFU (Instructions for Use)
BS EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices ISO/IEC Guide 37:2012 - Instructions for use of products by consumers (browse a draft here) IEC 82079-1:2012... (2,355 views, 7 replies)
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Ronen E
21st October 2017 01:52 AM
Sampling for stability studies - Class II surgically invasive devices
Hello northernscientist and welcome to the Cove :bigwave: I don’t think that the FDA has generic guidance for that. If there are clearly defined expectations for your device type I would look for... (74 views, 1 replies)
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DSurber
20th October 2017 11:19 PM
Which Medical Device Standard Registrar would you recommend?
Assuming you're looking for an MDD Notified Body, you can search by device category on the Nando site. Search "EU Nando". Sorry, I'm not able to post the specific URL. (317 views, 4 replies)
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    

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