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Russ King
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President MethodSense, Inc.
President MethodSense, Inc.

53 followers
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Improving #FDA Reviews of Combination Products may be in the FDA's best interests – what are your thoughts? http://ow.ly/U0n7O 

#medicaldevice   #methodsense  
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The contributions engineers make to the medical device industry are both critical and substantial, and they should be considered throughout the regulatory process. Read on!

#methodsense   #FDAapproval   #medicaldevices   #engineering  
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IEC 62304 provides a framework for medical device manufacturers to develop software components. Avoid common pitfalls to conformance! http://ow.ly/MovPd 

#iec62304   #medicaldevices   #softwarecompliance   #Methodsense  
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Unravel the complexities of IEC 62304 with this presentation from MethodSense and FDAnews... Download the presentation for FREE! http://ow.ly/LxByc

#IEC62304   #FDAapproval   #Methodsense  
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Unravel the complexities of IEC 62304 with this presentation from MethodSense and FDAnews... Download the presentation for FREE! http://ow.ly/LxByc

#IEC62304   #FDAapproval   #Methodsense  

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It'll be interesting to note how the FDA evolves to address "superbug" transmission via reusable medical devices. 

#fda   #FDAregulations   #superbug  
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Don't forget the value of safety testing and risk management when commercializing your medical device! IEC 60601-1 is a critical step for you to pay close attention to. 

#IEC60601   #FDAcompliance   #safetytesting   #medicaldevices  
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