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Selling Joint Implants without a Validated Process

P

phloQS

#1
Hi all,

I have a big problem in our company. We have several machining processes and want to validate them, to fulfill the requirements of ISO13485 (special processes) and 21CFR820.75. The problem is, that the processes development itself is not finished yet, but we already want to sell the products. For this, we do a 100% end control of all products. In our opinion, all critical aspects are covered by tests. The IQ activities for the machining centres are done, but we are not able to do anymore, because there are still many changes in the different processes. Is it ok to sell the products or what else could we do?

Regards

phloQS
 
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qusys

Trusted Information Resource
#2
Re: Selling without a validated process

Does the product meet customer requirments? Do you have a contract or P.O with your customer for this supplying? Did you sign off a PPAP ? Did you qualify your product with acceptable results for the customer? Do you have enough capacity and capability to ensure the agreed supplying with linearity?

Do you have some plan to fix eventual still pending issue? What is their criticality? How do you manage the risk for the product?
In brief, which are the criteria that you have set to say that a product is ready to the market?

These are some of the questions, but not limited to, you could think at. :bigwave:
 
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M

MIREGMGR

#3
Re: Selling without a validated process

If you're selling components to some other company and they're a medical device manufacturer but you're not, per 21CFR 807, I don't see a problem with 21CFR 820. If what you produce meets your customer's specs, and if they choose to control that conformance via verification rather than validation, you're good to go.

If on the other hand you want to sell your products as medical devices, your situation is more complicated. If your products will be USFDA Class I and exempt, you may be OK. It however is likely to be difficult given your circumstances to convince FDA to approve a 510(k) or other pre-market clearance.
 
G

Gert Sorensen

#4
Re: Selling without a validated process

A bit more detail about the products and your company may help us help you. As listed above, whether you are supplying or manufacturing for distribution matters. The product also matters. So, please provide more detail.
 
P

phloQS

#5
Re: Selling without a validated process

The products are joint implants and we are selling them as medical devices. We are in the european market since about 20 yeras. We never had a problem with the german NBs. They alwayws accpeted our endcontrols. But now a consultant told us that we definetely have to validate NC-processes as they are special prcoesses according to 21CFR820.75. I am honest, in my opinion we do not need a full validation in regard to safety because of our strict end-controls. Of cource we also have maitenance plans and traings for our staff and so on. But now we collect all this in a validationrecord. We wanna test our nc cutting machines with a standard nc-programm made by NCG (German NC-Association). Would that be ok for OQ? After that, we do a performance check by collecting and analysing data via our CAQ-Software. The basis of all this was a risk analysis based on the key attributes of our implants (surface,dimensinal stability, tolerances of position).

Rgeards

phloQS
 

somashekar

Staff member
Super Moderator
#6
Re: Selling without a validated process

Hi all,

I have a big problem in our company. We have several machining processes and want to validate them, to fullfill the requirements of ISO13485 (special processes) and 21CFR820.75. The problem is, that the processesdevelopement itself is not finished yet, but we already want to sell the products. For this, we do a 100% endcontrol of all products. In our opinion, all critical aspects are covered by tests. The IQ activities for the machining centres are done, but we are not able to do anymor, because there are stuill many changes in the different processes. Is it ok to sell the products or what else could we do?

Regards

phloQS
I am also wondering if you had been all along making things in some controlled way and meeting the requirement, and that you now are looking at validation of your processes in retrospect to fulfill the requirements with the ISO13485 .. ?
Can you comment please ?
But now a consultant told us that we definetely have to validate NC-processes as they are special prcoesses according to 21CFR820.75.
Ahhhh something wrong here. Please help us by listing your processes that makes your devices. You may not have a validation of processes requirement....
 
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G

Gert Sorensen

#7
Re: Selling without a validated process

The products are joint implants and we are selling them as medical devices. We are in the european market since about 20 yeras. We never had a problem with the german NBs. They alwayws accpeted our endcontrols.
OK, so you have been on the european market for 20 years. How long have you been on the american market?

But now a consultant told us that we definetely have to validate NC-processes as they are special prcoesses according to 21CFR820.75.
Special processes should usually be validated, however for NC cutting it is not per definition required (GHTF/SG3/N99-10:2004 (Edition 2), section 3.2)

I am honest, in my opinion we do not need a full validation in regard to safety because of our strict end-controls. Of cource we also have maitenance plans and traings for our staff and so on. But now we collect all this in a validationrecord.
I think you should be able to demonstrate that inspection is enough, depending on the output and the inspection.

We wanna test our nc cutting machines with a standard nc-programm made by NCG (German NC-Association). Would that be ok for OQ? After that, we do a performance check by collecting and analysing data via our CAQ-Software. The basis of all this was a risk analysis based on the key attributes of our implants (surface,dimensinal stability, tolerances of position).
You should validate the NC-software, and qualify the equipment, all based on your risk asessment.


:bigwave:
 
M

MIREGMGR

#8
Sec. 820.75 Process validation.

(a) Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures.
When a product can be and is verified as to conformance to specifications, and particularly if you have a significant body of historical evidence supporting your risk analysis and clinical safety/effectiveness stance to the effect that those specifications are sufficient to assure safety/effectiveness, I don't understand why it would be stated by your consultant that validation is required.

Of course, if you were arguing that verification were possible but you weren't actually verifying every unit, that'd be a different kettle of fish.

But if each unit of product is verified, I think you're good to go.

But now a consultant told us that we definetely have to validate NC-processes as they are special prcoesses according to 21CFR820.75.
21 CFR 820.75 does not include the word "special". Per my reading, there is no text in this section that defines some processes that must be validated and cannot be verified, other than that which is quoted above.

OK, so you have been on the european market for 20 years. How long have you been on the american market?
Many joint implants are FDA Class II devices. If you're already marketing in the US, there must be a 510(k), filed either by you or if you've been a 21 CFR 807.65 component maker for someone else, probably by them. What does it say about validation and verification?
 
C

cuteprettyone

#9
Hi all,

I have a big problem in our company. We have several machining processes and want to validate them, to fulfill the requirements of ISO13485 (special processes) and 21CFR820.75. The problem is, that the processes development itself is not finished yet, but we already want to sell the products. For this, we do a 100% end control of all products. In our opinion, all critical aspects are covered by tests. The IQ activities for the machining centres are done, but we are not able to do anymore, because there are still many changes in the different processes. Is it ok to sell the products or what else could we do?

Regards

phloQS
Validating "special process" is focused on the changes in manufacturing that can affect product characteristics and ensuring the PROCESS that is used to produce the product does not adversely affect the finished goods.

It depends on the process and the output of the process. For example, EDM process can cause heat affected zones, recast, and microcracking. If you can inspect/verify that each product manufactured on the EDM is free of heat affected zones, recast, and microcracking (defects that can be caused by the EDM process) then validation is not required. However, if you cannot the process must be validated even if the process manufactures each feature within specification. Validation is focused on the PROCESS and the impact the process can have on the product.
 
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