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Hello Folks ,
Here is a link of the OTS software guidance doc ,
http://www.fda.gov/medicaldevices/d...guidancedocuments/ucm073778.htm#_Toc458569098
in which OTS software defined as a generally available software component, used by a medical device manufacturer for which the manufacturer can not claim complete software life cycle control(I consider OS can be classified as OTS software as per this definition).
And here is the link of Premarket submission of the software . On the page no. 11 , OTS and OS are mentioned as different components (As per this point they are different).
http://www.fda.gov/downloads/medica...onandguidance/guidancedocuments/ucm089593.pdf
so should I consider OS as an OTS software ?
Thanks in advance .
Here is a link of the OTS software guidance doc ,
http://www.fda.gov/medicaldevices/d...guidancedocuments/ucm073778.htm#_Toc458569098
in which OTS software defined as a generally available software component, used by a medical device manufacturer for which the manufacturer can not claim complete software life cycle control(I consider OS can be classified as OTS software as per this definition).
And here is the link of Premarket submission of the software . On the page no. 11 , OTS and OS are mentioned as different components (As per this point they are different).
http://www.fda.gov/downloads/medica...onandguidance/guidancedocuments/ucm089593.pdf
so should I consider OS as an OTS software ?
Thanks in advance .