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Medical Device Manufacturing Equipment Design

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Leticia L

#1
Hello!:bigwave:

I am designing a polymer processing machine for my thesis. It must be able to produce long-term implants, and I have not found much information about requirements or qualification procedures for equipment used to manufacture this kind of medical devices (Class IIb in the EU and class 3 in the FDA, I believe)

I have read some parts of the GMPs and the ISO 13485 Standard, but they refer mostly to the process, not the equipment.

Any information regarding this qualification requirements in the EU and/or US regulations, (or design guidelines, if possible) would be really appreciated.

Thank you in advance for your help!
 

Ronen E

Problem Solver
Staff member
Super Moderator
#2
Hello!:bigwave:

I am designing a polymer processing machine for my thesis. It must be able to produce long-term implants, and I have not found much information about requirements or qualification procedures for equipment used to manufacture this kind of medical devices (Class IIb in the EU and class 3 in the FDA, I believe)

I have read some parts of the GMPs and the ISO 13485 Standard, but they refer mostly to the process, not the equipment.

Any information regarding this qualification requirements in the EU and/or US regulations, (or design guidelines, if possible) would be really appreciated.

Thank you in advance for your help!
Hello and welcome to the Cove :bigwave:

I'll start from the end - I'm not aware of any publicly available design guidelines for this kind of machines. If I had to do that I'd take the long way of paper search and sifting through :(

For the equipment qualification requirements / guidance, search Elsmar for IQ/OQ/PQ and/or Process Validation in the context of medical devices. There are a lot of threads on these, a tag search might come handy. Also have a look at the attachment (from the late FDA QS Manual).

[My background: mechanical engineer with polymer processing background in the medical devices industry.]

Cheers,
Ronen.
 

Attachments

L

Leticia L

#3
Thank you for your help, Ronen. I will check the file and the forums you recommend. :)
 
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