ISO 13485 Design Requirement with respect to "component" manufacturers

KarenA01

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#1
Overview of what we do for context:

We don't make medical devices or software and are a small company. We do contract fermentations for enzymes/biologics (and will eventually have our own products) that may be used by companies that make diagnostic kits and/or vaccines - They would be components for such things... BUT would be technical grade which our customers would then polish and either use themselves or sell to others to incorporate into such products. So it's more like a crude chemical the the customer refines before using in their Diagnostic kit or vaccine production rather than a direct device component component,

We are recently ISO-9001 certified but with a design exclusion. Since then have both decided to become ISO-13485, Keep 9001 AS WELL as develop our own product that fits the one category I mentioned above.

So my question, since our potential product is not a medical device or something that is sued as is in a device, would it be covered under the Deign causes of 13485?

For sure we have to change our ISO9001 registration to include design, but would it's design fall under 13485?

BTW In General I know ISO9001 is less proscriptive than 13485, Does that apply to design as well for 13485 Vs 9001?

Is this a stupid question? (meaning no significant difference?)

Thanks,
-Karen
 
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#2
There is no need for you to get certified to ISO 13485 right now. I wouldn't do that until you have a customer that requires it. You can still be compliant to the standard without being certified, and then get certified when the timing is right. But wait, are you sure your products won't be considered reagents? Reagents may be considered medical devices.

If you are designing your own products for sale, then design for ISO 9001 would apply to you. From what you said above, it is not clear whether ISO 13485 would apply. I think you need to figure out specifically what you will be making that this medical related, and then come back here and ask more questions.
 

KarenA01

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#3
If you are designing your own products for sale, then design for ISO 9001 would apply to you. From what you said above, it is not clear whether ISO 13485 would apply. I think you need to figure out specifically what you will be making that this medical related, and then come back here and ask more questions.
I know what we are planning to make and it has both medical and non-medical applications.

The medical applications are likely more money, but the non medical ones are significant as well... But as I said we won't produce even a finished component. The biologics we supply would be further processed/purified by customers before use in a medical product

So we are NOT required to be 13485 to sell for medical use of what we produce. We know that.

But we are starting a 13485 implementation now because we are a small company and a newish entry into this type of work. The belief is that being 13485 would make potential customers for medical uses more comfortable buying from us (not only fro the product but also for contract manufacturing) ...

Because of that the company president has decided that we will get 13485 upfront and not wait for a customer to ask for it.

While the current IS013485 standard says we should be able to get certification, it is far from clear how some of the clauses would apply to a company like us as we don't make medical devices and only indirectly make things that MAY, after additional processing go into them.

That is what I am trying to figure out and why I am asking questions here now.

-Karen
 
#4
If you are designing a medical related product, and you claim compliance to ISO 13485, the design and development sections will apply. Note that a “product” per ISO 13485 is “the result of a process” rather than a medical device.

Your quality system should be set up so that different products with different applications have varying levels of controls based on the associated risk. For example, only some of your products (the ones used in medical devices) will require a design history file. And you should determine whether this is required based on your customer’s requirements.

This is a lot. I wish you the best.
 

KarenA01

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#5
Previously you wrote:

indubioush said:
But wait, are you sure your products won't be considered reagents? Reagents may be considered medical devices.
We have gotten a bit more clarity about potential products and customers since my last post .

In some cases our products will definitely be used in medical devices/ diagnostics kits, through that may be only after further purification by our customers- technical grade. In some cases we may get to sufficient purity for "reagent" grade, but we don't know that right now.

In some cases they would be used in the manufacture of vaccines.

In some cases products will have usage in both R&D as well as as the above medical cases ... but as we want to sell in bulk, we want to concentrate on the medical market...
Though if someone wanted to buy in bulk from us and then sell to the R&D market, for the right price, I'm sure we would sell to them

If you are designing a medical related product, and you claim compliance to ISO 13485, the design and development sections will apply.
The big question here that is getting debated is if our "development" actually falls under design in 13485... (more on that later below)


With that background please let me pick your brain (as well as that of others here) for and about the design requirement for 13485. In our situation it seems ambiguous to many here...

If we definitely need design we will go for it, but if we don't we don't want the overhead that adds and would take an exclusion.

Alternatively we would want enter the "Design" phase as late as possible (see later below).

The fear is how much it would slow us down bringing product to market... We are a small company that is in the process of establishing ourselves in the industry.

We will never have our own product/enzyme that is not already on the market. We don't do that type of basic R&D ...

What we will do is target something already being sold by others that is off patent... and develop it based either on the expired patent or what is in the literature.

We would either license an organism or make our own clone to express the the enzyme in an organism to produce it... and again using those sources mentioned above develop the fermentation and purification processes.

This could be considered process development rather than product development... a pharma analogy would be producing a generic drug.

So for products "developed" that way which will be used in an in vitro diagnostic kits/devices, would need to include design in our 13485 registration?

What if we get the specifications to be met (but not the manufacturing process) from a customer?
What if we would then sell it to others beside the original customer?

If we do need design, then when does it need to "start"?

We don't know if we will develop a specific enzyme as a product until after we create or get a clone and develop at least small scale fermentation conditions which indicates it will express enough enzyme to make scaling the process up and working out the purification details to make it financially viable for us. Before that the finical risk are too high to proceed.

So if we do need design could it just "start" it after some initial work to determine commercial feasibility ...basically only when we have enough data to make an informed business decision if we should try bring it to market.

Your quality system should be set up so that different products with different applications have varying levels of controls based on the associated risk. For example, only some of your products (the ones used in medical devices) will require a design history file.
Assuming in the above situation we needed design in 13485 and
let's say we "developed" the product for non medical use, but then someone wanted to include it in a medical device but If we don't have the appropriate design records?

Would that cause issues for 13485 auditors?

Basically if we can get certified without design while doing the type of development I described ... we would exclude it.

This is a lot. I wish you the best.
Thanks...

We are hoping being 13485 certified will help us land medical related customers...

Most of what we need to do OUTSIDE of design to meet the standard is clear. But the design requirement (if any) in our situation is far from clear...

I would really appreciate feedback/discussion here about this!

Thanks,
-Karen
 
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#6
We are hoping being 13485 certified will help us land medical related customers...
I think you need to do a bit more research on this. I have never worked for a company that requires its component/material suppliers to be certified to ISO 13485. It is my opinion that your company does not need to get this certification.

If you are certified to ISO 13485, and you perform design and development of product, section 7 will apply to you. You can write up your processes so that you have some R&D only products, but yes, you will have to have the appropriate records when that product converts to being used in a medical device intended for human use. Also, you must not mislead your customers into believing that the products they are buying from you have a design history file and other records when they don't. Chances are your company will evolve with your customers. Their product will start off as R&D and go through phases of development. If at some point they determine they want you to be certified to ISO 13485, then that is when you should consider it.

Please, someone enlighten me on any benefit of a raw material or component supplier being certified to ISO 13485.
 

Sidney Vianna

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#7
Please, someone enlighten me on any benefit of a raw material or component supplier being certified to ISO 13485.
There are none, realistically speaking. Sometimes snake oil consultants manage to convince owners of small organizations that they could insert themselves into supply chains that command premium pricing if they attain more “exclusive” certificates such as AS9100 for aerospace and ISO 13485 for Medical Devices. But, as mentioned above, these standards bring requirements and complexity that those organizations can’t comply with, in a meaningful and cost effective way. It should go without saying that these special schemes demand higher costs from CB’s and auditor scarcity.

So, for the most part these “artificial” certificates are just an empty marketing plot. When the new business doesn’t materialize, they drop the special scheme certs as hot potatoes.
 

KarenA01

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#8
I think you need to do a bit more research on this. I have never worked for a company that requires its component/material suppliers to be certified to ISO 13485. It is my opinion that your company does not need to get this certification.
It is not REQUIRED for us to be 13485 ... but need has more dimensions than that.

We have a major customer whom we do contract manufacturing for who sells reagents and they told us we would likely get a lot more medical related business if we are 13485 certified... That was their experience.

I also have a family friend who is a retired supplier quality engineer from a major medical device company and he says it would be a marketing advantage...

BTW the most we would ever do would be to supply bulk enzyme "reagent" which could be considered a part of a medical device (or used in vaccines) ...

Over the weekend through google I found that in 2017 the FDA decided that Reagents are Class 1 devices, so if that applies, we would not need design.

Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Reagents for Molecular Diagnostic Instrument Test Systems. Final order

If my understanding is correct, all we need are general controls and not design...

As we intend to maintain dual 9001 and 13485 certs, the question would then become if we need design under 9001... and the answer to that seems to be no, as long as we only develop processes to specs of products already on the market and no new chemical/biological entities or grades ... see:

Determining the applicability of ISO 9001 Clause 8.3- Design and development of products and services

Is anyone willing to comment on if that logic is correct? It would make our R&D (OK process development) group and the company president very happy! But we need to make sure we do meet requirements... so I would appreciate it that if someone thinks I'm misinterpreting things they would explain why they think that!

Chances are your company will evolve with your customers. Their product will start off as R&D and go through phases of development. If at some point they determine they want you to be certified to ISO 13485, then that is when you should consider it.
We are committed to getting 13485 - and it looks like we can do it without design ...if that is correct, at some point design in the future was needed, we could then increase scope to add Design .

Again I a newbie at all this even though I am head of quality (and the only person in quality!) ... As I said before until fairly recently we were a company working in a very different area doing only R&D in very different industries. None of us have real quality experience even though a few of us have worked in different capacities in pharma...

Interpreting how to implement these standards almost seems to be an art form of it's own! Any advice/discussion would be greatly appreciated, if if you don't think we need or should be 13485... I don't have a choice about that.

Thanks
-Karen
 
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KarenA01

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#9
Over the weekend through google I found that in 2017 the FDA decided that Reagents are Class 1 devices, so if that applies, we would not need design.

Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Reagents for Molecular Diagnostic Instrument Test Systems. Final order

If my understanding is correct, all we need are general controls and not design...
Reading through the FDA regualtion... it's not quite so absolute.. It depends on how the reagent is used... it says"
"and it is identified as reagents other than analyte specific reagents used as part of molecular diagnostic test systems,"​
In some cases it would not and in some cases it would not be analyte specific <sigh>

-Karen
 
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KarenA01

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#10
I'll try to distill what I'm asking here to come basic question... For producing enzyme than can be called reagents, when would 13485 design requirements start... What defines the transition between R&D feasibility and design?

As we are not doing basic research , just developing the a way to make products that are already on the market made by others.

Some here are of the opinion that we can define when design starts only when we decide to decide that we are definitely going to manufacture the product...

That means we have already either obtained or cloned an organism to produce the enzyme, verified the produced enzyme's biological activity, developed or are able to develop fermentation conditions where it is expressed in large enough amounts to be commercially viable, and have convinced ourselves that we can purify it reasonably.

To me that sound like the only thing left would be scaling up to manufacturing scale... I say only, but I know that is often not an easy task...

But it seems to me that to reach that point one already has to have some specs and almost all the development not directly related to scale up issues have been done.

In general it seems to be both 13485 or 9001 design models more easily apply to mechanical products than chemical/biological agents.

So when does design have to begin? I am really struggling with this and am getting a lot of pressure to define it as when we get to the scale up phase... but that just does not feel right to me.

Thanks,
-Karen
 
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