Medical Device file and "Component" Manufacturers?

KarenA01

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#1
And Overview of what we do for context that I have posted before:

We don't make medical devices or software but 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...

Ours would be technical grade which our customers would then polish and either use themselves or sell to others to incorporate into such products. We know other companies who do such things are 13485 even though they don't make medical devices.

We supply biologics , not hardware or software, and those would require further processing to to get incorporated in a diagnostic kits.

As such, even though it would not be required, management believes it would help us in that market to be ISO-13485, and we are starting on that path (we just recently got ISO-9001 certified and are looking to have/keep both).


Now my question... Do we need Medical Device Master Files.... I don't understand how that would apply to us or what we would have to do to comply...

In such a situation can one take an exclusion on that requirement? If Not how would one fulfill it?

Thanks,
-Karen
 
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KarenA01

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#2
Also to be clear the product we are considering developing , while it is something that could be used in Diagnostic Kits and Vaccine manufacture , it also has wider market fir use in non medical biological assay applications.
 

Zero_yield

"You can observe a lot by just watching."
#3
Hopefully someone will have more direct information, but I will say: When our NB comes to audit, we explicitly list which organizational responsibilities are owned by which group.

For context, I work for a large med dev manufacturer. Our R&D isn't on site, so we list global R&D as the group responsible for design activities. Our site is responsible for the design transfer from R&D to Manufacturing. I would assume suppliers would have similar setups, where certain portions of the regulation would be not applicable.

Not an expert on this particular question, so hopefully some is able to give more concrete advice.
 

EmiliaBedelia

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#4
Are you talking about FDA master files, or about device history files, or about something else?

Master Files are a specific thing that you would have on file with the FDA. The purpose of a master file is so that you can provide your own proprietary information to FDA, and then another company can reference it for use in their own submissions, without you having to provide your information to them. This is really common with contract suppliers/manufacturers like yourself, where they need to provide information for their customers' submissions but they do not want to give it to their customer. Often it's a "standard" file, so you would just submit the file to FDA and then each customer could just say "Reference Master File #12345 for information on biologic product ABC". This is optional and not required if you intend to just provide all the documentation to your customers.

If you're talking about a DHF, just a general file of all the device information... I don't think you can fully get out of the requirement to keep records/evidence of your product and requirements, I think it will just be slightly less detailed than if you owned the device yourself. Honestly I am not familiar with biologics/IVDs so I'm not sure what that would look like for you, but good documentation policies should be your first step. You can probably be exempted from a lot of the design and development requirements based on your scope, but I would assume you need some level of document organization just to have on hand what your customers would need. This article talks about some of the high level requirements of a DHF, obviously you should reference the standard itself but this is a good 5 min. overview. ISO 13485 Medical Device Design Records

One thing to consider is that if you are listed as a critical subcontractor/crucial supplier for a company, you may get audited on their behalf. So, while you may not be the product owner, you would need to demonstrate that you are able to meet their requirements and that the documentation you have supports what you are doing for the specific products you make for that customer.
 

KarenA01

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#5
If you're talking about a DHF, just a general file of all the device information...
YES... But as what we sell will not be a device and is more like a technical (crude) grade chemical, it's hard know what would be expected for 13485 beyond such things as normal product specifications, manufacturing and testing procedures .

It would be a product already on the market made by others and we would just be shooting to match their specs.

As we are also keeping ISO-9001 we have to add design to that registration, but I am not sure if it would need to also have design under 13485.

One thing to consider is that if you are listed as a critical subcontractor/crucial supplier for a company, you may get audited on their behalf.
That happened to us even before we were ISO-9001! It was by cosmetics company considering using us. How they audited us basically got us thinking about 13485 because their audit was close to a cGMP audit in what they expected!

-Karen
 

EmiliaBedelia

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#6
So, here is my 2 cents. You should consider what you actually want to achieve from being ISO 13485 certified. From what you're saying, you don't necessarily need to be certified, your management just thinks it will be attractive to customers. Sure, fine... However, if you are just going to exclude a bunch of clauses, then what capability does your cert actually show? You already know that it's not a requirement for you, so you don't "need" to do anything... but personally I think if you are doing the work to get certified, you might as well include design as well, because most likely you already DO have a lot of that documentation, you just need to proceduralize it.

There is an entire clause about customer requirements that would be relevant to your activities, and the requirements about specifications, verification/validation, change control would also be relevant to you. The "design and development file" requirement is literally 2 sentences and extremely high level - I think it would be very easy to define what level of documentation you need based on the design activities you are actually performing, and justify exemptions to the specific elements (eg, "any user training needed to ensure specified performance and safe use of the medical device" would not be relevant to you). Again all of this is probably something that you are already doing as part of your current process, so write it in a procedure and show it to the auditor and get credit for that work.

I commented this in another very similar thread recently, but I think as a supplier it is important for you to understand what requirements your customers are responsible for meeting, and what role your product plays within the device (see the purchasing controls section of 13485 for more detail). You are not responsible for the "patient" facing aspects (eg, translating patient needs into design inputs, and postmarket requirements), but you are responsible to make sure your device meets the specifications that the manufacturer gives you. IMO that still counts as "design" to some extent, even though you aren't the device manufacturer.
That happened to us even before we were ISO-9001! It was by cosmetics company considering using us. How they audited us basically got us thinking about 13485 because their audit was close to a cGMP audit in what they expected!
-Karen
Your customers' notified body may actually audit you, not just your customer. As in, the NB will pull the medical device manufacturer's certificate, look at their suppliers, and pick one to audit, with no warning to the medical device manufacturer or to you. Personally I think this is even more challenging than an audit by your customer, because they at least have some level of interest in working with you!
 

KarenA01

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#7
So, here is my 2 cents. You should consider what you actually want to achieve from being ISO 13485 certified. From what you're saying, you don't necessarily need to be certified, your management just thinks it will be attractive to customers. Sure, fine... However, if you are just going to exclude a bunch of clauses, then what capability does your cert actually show?
Thanks for the info.

It looks like me are going to include design even though we would not feeling anything directly into the medical market but only biologic "reagents" that may get incorporated into a medical device by some of our customers.

In any case the consultant we met with yesterday told us that even with the above, for the purpose of certification. those "reagents" are considered to be the device, as in 13485 it defines a medical device as:
3.11 medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use <snip> intended by the manufacturer to be used, alone or in
combination, for human beings, for one or more of the specific medical purpose(s) <snip>
Which brings up some interesting questions for us on applying some aspects of the standard, but I'll start new thread about that.

Thanks,
-Karen
 
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