Scope of ISO13485 and the term 'Related Services'

shifter

Registered
Hi Folks,

Can anyone define for me what 'related services' entails under the general scope of ISO13485. The standard applies to 'medical devices' and 'related services'. It's this element that I would like some guidance on, the guidance document ISO14969 does not give any information in this area.

Thanks:confused:
 
M

MIREGMGR

An example:

Some medical devices require calibration or maintenance. Calibration and maintenance services don't meet the definition of a medical device, but they are related to and supportive of medical devices, which might not function safely and effectively without those services.

So, 13485 applies to such service provision.
 
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