Creating DHF (Design History File) for Medical Device Systems

L

Lbrager

#1
When creating a DHF for a new product that is a system - in this case an IVD instrument with consumables ie. various assays, what is the best approach for organizing the DHF? Create it at the systems level (instrument and assay together) vs. 1 DHF for the instrument and another for the consumable? In particular if there will be multiple assays or consumable types that can be used with instrument does that dictate structuring the DHF differently? I know there are several schools of thought on this but when you start adding new products to an existing platform, this is when it gets to be more critical as to how you structured the DHF from the beginning.
 
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sreenu927

Quite Involved in Discussions
#3
Hi,

First of all, in what way you want to maintain your DHF? As a large binder file or just an excel spreadsheet that references various documents?

For case ii) of excel spreadsheet, I do the following manner:
- put all the design elements such as D&D, DI, DO, DR, DVer, DVal, DT and DChange
- in each row/section, populate the documents. say for eg, under D&D you can put the development plan and any other functional plans as per your process.
In DI section, you can list down the requirements document, in DO section, specifications document, trace matrix document, risk assessment plan, risk assessment report, design drawings, etc..and in design review section, you can list down the various design review meeting minutes, followed by verification test plans, reports, validation test plans and reports, external validation, stability test plans and reports, package validation etc..in design transfer-any design transfer checklist, etc...
- for DI -product requirements document, we may have many PRD docs, each for instrument, SW,consumables, Assay and the specifications document will call for all these PRD docs, in a way, a system level PSD doc.
Many PRDs and one PSD.
- but when there is a scope to add multiple assays, then I suggest to have 2 DHFs, one for instrument (HW+FW+SW+Consumables) and another one for Assay related and it's associated kits, if any. But you need to have a link between these two. If the instrument takes multiple assays, then this has to be mentioned somewhere in the requirements/specifications document.

Hope this helps!

Regards,
Sreenu
 

yodon

Staff member
Super Moderator
#4
I encountered a similar situation with one of our customers. Their "product" comprised an electro-mechanical device, a set of consumables, a separate consumable that was a stand-alone device on its own, and a reusable component that was also a stand-alone device.

I started out trying to just have 1 DHF but quickly realized that was not going to work. I then broke it up into 3 DHFs, one for each stand-alone device with the 'primary' device DHF including the non-stand-alone-device consumables. So far, that's working out but it's not always easy with the consumables since they are managed somewhat independently of the primary device.

By the way, Sreenu mentions linkages between all of them - we accomplish that 2 ways: through high level specifications and through the BOM for a kit (a kit containing all 3 devices, consumables, accessories, etc.).
 
L

Lbrager

#5
:thanx:

Thank you both yodon and sreenu927 - these are very helpful suggestions. If there are any useful DHF templates you can provide to help index and better structure a DHF binder that would be appreciated. I intend to have a DHF binder for each phase with an index that includes pointers to many documents with some key phase deliverables - Project Plan, Phase Review approvals, FMEAs, Risk Management Plan and Report, Product Reqt's, and a few other essentials. If either of you use the index approach, in an audit situation do you just provide index to the auditor of the deliverables for each phase and let them specify what they want to see? Do you update the index each time a revision level of a DHF deliverable changes and/or you create a new deliverable for a previous phase? Does your index go through change control/document control?

Thanks!
 
D

Deep Krothapalli

#6
I wouldn't provide entire DHF binder in audits unless was asked for. I would start with DHF index, and provide any additional documentation.

DHF does not need to be revision controlled, as long as the revision levels of documents referenced in DHF are under change control.

Deep
 

yodon

Staff member
Super Moderator
#7
Like Deep indicated, we wouldn't automatically provide all the docs in an audit, only the index and then let the auditor ask for specific ones.

I'm not inclined to put the DHF index under revision control. To date, history of changes to individual documents cited by the DHF has been sufficient.

I *do* put the DMR (index) under revision control.
 

robert.beck

Involved In Discussions
#8
I have a related question. Normally, we generate a detailed DHF for all devices, but now we're starting make accessories which are quite a bit simpler than our previous devices. how far to we have to go with the DHF? we have a five-phase design and development process with lots of required documents, but for these simpler devices the process is seen as overkill.

looking through FDA's documents, I don't see much support for a two-tiered approach? any ideas?
 

Ronen E

Problem Solver
Staff member
Moderator
#9
I have a related question. Normally, we generate a detailed DHF for all devices, but now we're starting make accessories which are quite a bit simpler than our previous devices. how far to we have to go with the DHF? we have a five-phase design and development process with lots of required documents, but for these simpler devices the process is seen as overkill.

looking through FDA's documents, I don't see much support for a two-tiered approach? any ideas?
Look at the accessory's classification first. Some accessories will come under a dedicated classification, which may provide some exemptions relative to the parent device. Otherwise the accessory will come under the parent's classification. In the latter case, look for any specifics in that classification, that may provide a reduced burden. If none are there, you'd probably have to apply the whole lot. If the accessories are indeed simpler, then maybe you won't be able to skip any steps but the steps themselves will be easier.

Cheers,
Ronen.
 
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