Jnks_Meddev

Involved In Discussions
#1
Hello Everyone,

I am checking failure modes on FDA websites (TPLC?) for our device and see if there's competitor's mode data/existing data.

Can someone guide me on how to look up for failure modes on FDA website?

Thanks!
 
Last edited:

Marcelo Antunes

Addicted to standards
Staff member
Admin
#2
Medical device reporting does not explicitly requires that failure modes are reported, so you probably won't find specific ones (reporting are usually related to the patient event, not device failures modes (which are usually internal").
 

Jnks_Meddev

Involved In Discussions
#3
Thank you for responding! We are a contract manufacturing and so a lot of our products failure modes are not internally tracked as our clients will report it to the FDA and so we use TPLC TPLC - Total Product Life Cycle to find all failure mode's to make sure we have covered all of them in our DFMEA's.
 

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