What is CD writing considered as - for Device-Only SW?

sagai

Quite Involved in Discussions
#1
Hi World,
I have doubts ...

Does the CD writing of a SW only MD is production or packaging?

Thank you your thoughts in advance
Sz.
 
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G

Gert Sorensen

#2
Re: What is the CD writing for SW only MS?

If you write contents on to the CD I believe that it must be considered production.

If you write inserts for the CD i believe it must be considered packaging/labeling.
 

sagai

Quite Involved in Discussions
#3
Re: What is the CD writing for SW only MS?

I may need to clarify.

What is written on the CD is the installable finished medical device which is 1oo% software.
This is what the Customer receive in a paper box with printed accompanying documentation.

I do not know what does the "content" and "insert" considers to ... :confused:

Thank you
Sz.
 
G

Gert Sorensen

#4
Re: What is the CD writing for SW only MS?

I may need to clarify.

What is written on the CD is the installable finished medical device which is 1oo% software.
This is what the Customer receive in a paper box with printed accompanying documentation.

I do not know what does the "content" and "insert" considers to ... :confused:

Thank you
Sz.
The contents of the CD is the bits and bytes that are written on the CD itself. That is the product.

The insert is the paper insert that is usually in a CD-box (you know, the acrylic cases that contains the CD). That would be the packaging/labeling.

:bigwave:
 

sagai

Quite Involved in Discussions
#5
Re: What is the CD writing for SW only MS?

you know, the acrylic cases that contains the CD
:lmao:


What if the CD would be only part of the packaging?

When there is a downloadable way to install the finished medical device (from website for example) than ultimately the CD could be interpreted that not part of the finished medical device, only an alternative packaging way to deliver the device to Customer.

Thoughts ... ? ...
Sz.
 
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