In addition to the standard, what other ISO 13485 sources do people recommend?

O

outdoorsNW

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#1
#1
If one is in the process of implementing ISO13485, what sources (other than the standard) do people recommend?
We are already AS9100, so I am more interested in ISO13485 specific vs. general QMS type sources.
We are a contract manufacturer, so no design.
 
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Tagin

Tagin

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#2
#2
This from ISO.ORG is likely helpful (I haven't bought it):
ISO 13485:2016 - MEDICAL DEVICES - A PRACTICAL GUIDE

Edit: and ISO 14971 - Medical devices — Application of risk management to medical devices

Edit2: Even though you are a CM, the requirements placed on you will vary with your customer. Some customers might not only audit you to 13485 but they may also want to push some FDA controls for medical devices to you as well.
 
Last edited:
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DannyK

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#5
#5
I have helped several contract manufacturers with both ISO 13485 and AS9100.
The biggest issue with implementing ISO 13485 is software validation. If you have an ERP system or other software used in the manufacturing process, then you may have to spend quite a bit of time validating these software.
 
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