My little ISO 9001:2008 plant is going to make a medical device...now what?

M

MIREGMGR

#21
Will it require another person or additional resources to get the 21 CFR 820 classification?
sagai said:
there is no such thing
I agree that there is no such thing as 21 CFR 820 classification of a facility, but my impression was that the former statement pertained to the product.

The FDA does provide a process for establishing the classification of novel, difficult-to-classify products. This however usually is applied to products that might be either Class II or III, with their manufacturers usually hoping to convince the FDA to consider them Class II.

In the case of a product that someone considers likely to be either Class I or II, usually a person with sufficient device regulatory experience will be able to determine a defensible classification based on precedent, i.e. your product will have the same classification as another company's earlier-introduced product to which it is sufficiently similar. Because there is so much history of prior products in the US device regulatory system, this is almost always straightforward.

If need be, your company might want to consider briefly hiring a consultant to determine, and provide you with memos-to-file justifying your stance on, these regulatory basics.

As mentioned earlier, a Class II product must have a 510(k) to be marketable. If your company in fact is the Manufacturer and will have to get the 510(k), I'd think you'd be likely to need some experienced help in preparing the submission. I don't know very many people who would enjoy the experience of preparing and interacting with FDA on a current-expectations 510(k) as their first regulatory task. It's a lot of work, and there are plenty of opportunities to make beginner-mistakes that result in a negative FDA initial review and way more work digging out of avoidable holes.
 
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sagai

Quite Involved in Discussions
#22
only one more note, may be useful.
in FDA term it is called predicate device, likely there is.
you can find by yourself the classification based on analysis of 21CFR862-900
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

or less painfully, if you know competitor having a cleared md, search their 51ok, using:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

than you have a predicate, as well as the related CFR for classification.

br
Sz.

ps.: you also can search their warning letters to gain impression of the problem could also affect you (and be prepared to avoid those) :p
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm
 

wooden nickle

Involved In Discussions
#23
The real questions are: Who is the Specification Developer and who is the distributor? The specification developer and the distributor must register and list.
 
X

XIO549

#25
Hi Djbeatsent

Since your last post in Nov have ye decided what route to take?

I am interested, as I work for a small Toolmakers firm also with similar circumstances.

We are applying for ISO9001 at the moment, and the question was raised that as we are involved in the medical device manufacture
[albeit we design and make the mould in which the medical device is formed] should we go for ISO13485 standard also.

I've asked this question here and have received sound advice I feel.

Essentially, we wondered about going for 13485 because (a) it would demonstrate that we know what our clients needs will be, and (b) because it would help in our processes in this area.

We have decided not to go down the 13485 (or FDA) route as essentially 'we do not make medical devices', or part thereof. That’s it in a nut shell.
No two ways about it.

Some advised that 13485 was a marketing advantage, sure, but others pointed out that the 'Risk' and Hygiene/Clean room requirements of the standard would prohibit the system from being workable in a 'Toolroom' environment.

We may re-visit this in a year at Management Review stage perhaps, but advice would be to show that you have a good ISO QMS and that speaks for its self, unless you really really want to bring the additional work upon the existing functioning 9001 system.

Hope that helps, from a fellow Tool Maker

Xio
 
D

djbeatsent

#26
We are still at a bit of a standstill on the quality side. We have been sending 20-30 here and there to our customer for samples, but we haven't got any PO's yet for a production run. I am just waiting on our customer to define what he is looking for in a quality plan. Until then, I am just making sure our ISO 9002:2008 QMS is in top condition.
 
M

MIREGMGR

#27
We have been sending 20-30 here and there to our customer for samples
What's your potential customer doing with the 20-30 part batches?

Various important rules would apply to their use in patient procedures, irrespective of "sample" status. You said above that the device would be US FDA Class III. Have you registered, and initiated the PMA process for the device? Or are you conducting a formal clinical trial?
 
D

djbeatsent

#28
Since the beginning of our involvement in this project I have been a little lost. We were asked to email "what type of quality system" we have for their submittal to the fda. I responded with our 9001:2008 certificate. Since then we have been submitting samples to our customer so that they can use them to show investors full units, as well as other contract manufacturers making electronics. I still have yet to hear any qms requirements, but that may be because our customer may be trying to sell full units to bigger customers...I'm just guessing.

The unit has been classified as a class 1 device.
 
J
#29
Just to butt in with my 2 cents worth - and I don't know if this would fly with in the medical industry but ----

Years ago I worked for a commercial manufacturer who was contracted to make product for nuclear power stations. Since we were not nuclear certified, management made it clear that, as a commercial supplier, we could not certify our product for nuclear use. The customer would have to do this by providing the necessary requirements as part of the P.O. This the customer did.

I used this same process at my next company where I was quality manager. We had a customer who had the opportunity to sell to nuclear power and wanted us to manufature parts for them (many of hte same parts we supplied to them commercially). I told them that we would manufacture "commercial parts" to whatever "special requirements" that they included in their P.O. but we they, not us, would be responsible for "certifying" the product for nuclear use.

This prevented us from having to jump through hoops of certifications and expensive procedures and paperwork for something that was a very small part of our business. They told us - in very practical terms, what was needed (mat'l certs and mat test coupons - inspection reports - finshed part samples etc.) We then came up with a line item charge for this paperwork package, I developed an in house forcedure for dealing with these orders and off we went. They were happy, we were happy and I didn't have a huge headache...(just a small one)

Peace
James
 
X

XIO549

#30
Hi Djbeatsent,

Taking a step back from the daily quality issues you contend with can I ask some questions to clarify your status in the mix.

1 - Are you a tooling manufacturing (mechanical engineering) company?
2 - or other ?
3 - Is this medical device 'your product' / did you design it?
4 - are you the Medical Device 'Manufacturer'?

If you are a tool maker for another company who are the medical device manufacturers, I'm finding that No, you dont need 13485. Your client (the medical device manufacturer) may require you to be 9001 approved more than likely, but thats it, end of.

Unless, the answers above say different.

Maybe you can clarify the above position in this scenario and that perhaps would assist you in getting clear and concise feedback and advice.

Xio
:cool:
 
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