Process Validation Training - Custom made Medical Device

W

WimVr

#1
First of all, thank you all for the great topics on the board, fantastic information gathering board.

We are producing custom made medical devices and for process validation there are a lot of external trainings available, but I cannot find any training which focusses on process validation of custom made devices.

Does anyone has experience with the AAMI training and if they address custom made products?

Or does anyone know any good training for process validation with focus on custom made devices, ideally in Europe, but if the trainings are worth it we can send some people to other parts of the world or invite the trainer to Europe.

Thanks!
 
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M

maaquilino

#3
I don't believe it makes much of a difference if a device is custom made or not. The definition for Process Validation means "establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications."

These may help:

http://www.imdrf.org/docs/ghtf/fina...g3-n99-10-2004-qms-process-guidance-04010.pdf

http://books.google.com/books?id=6I...validation custom made medical device&f=false

http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm114942.htm

http://ec.europa.eu/health/medical-.../notes-for-manufactures-custom-made-md_en.pdf

http://www.fda.gov/downloads/aboutf...fmedicalproductsandtobacco/cder/ucm334568.pdf
 
N

Nathan Phill

#4
Now, the thought of process validation of custom made devices made me think about it. Usually the process of validation happens is of three main stages: Process design & development, process qualification and process maintenance.
I guess, the main changes comes in design & development, but when you consider the process qualification, which is to evaluate if the process is capable of reproducible commercial manufacturing, does it have much importance in your devices? These are the ones that kept my thoughts busy with.
But, it is similar the process validation procedure of a product, but you have to do it for every single product that's all, I guess.

Source: Compliance Associates, ON.
 
G

gfellows

#5
If you're still looking for training, the best I have found is through CfPIE. They have a Process Valid for Med Device course.

Don't confuse them with CFPA, I'm not sure why their names are so similar but CFPA cancels most of their courses.
 
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