Equipment list

evan_kim90

Involved In Discussions
Hi, All

I have confusing for equipment list based on ISO13485 + MDSAP + MDR + FDA.

So what is the range of equipment we should add on system?
EX, For sure, caliper or measuring equipment has to be added in list and require to verificaiton.
But like software, Adobe, Dropbox, Solidwork, kind of this software has to be added in equipment list and control?

Thanks in advance for sharing opinion!
 

shimonv

Trusted Information Resource
Software tools / OTS are managed separately from equipment requiring calibration or maintenance.
 

evan_kim90

Involved In Discussions
Software tools / OTS are managed separately from equipment requiring calibration or maintenance.
Hi, @shimonv , Thanks for opinion, so it makes sense software tool managed separately, but kind of general software (Solidwork, Adobe, and others) has to be include in separated software list? Or it does not has to be in even list.
 

shimonv

Trusted Information Resource
Software that affects QMS or product quality should be listed. See ISO 18485 sections 4.1.6, 7.5.6, and 7.6.
 
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