Design History File (DHF) for New Generation of Product

#1
I work for a med device startup that is still in a development phase. The first generation product (GEN 1) has a well-laid out Design History File (DHF), maintained both in an index and a separate hard copy set of documents, but will not be developed further.

GEN 2 has some significant changes but is basically an evolution of GEN 1. I intend to only maintain an index as keeping a hard copy set seems a waste of time, although the auditors like it.

Should all the documents in the GEN 1 DHF be included in the GEN 2 DHF? There would then be 2 sets of customer requirements, product requirements, user requirements, software development plans, etc. If so, should I identify each document as being for GEN 1 or GEN 2, or both?

I took over this project from my predecessor and did not have input into the first DHF.

Thanks in advance for your help.
 
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#2
First and foremost: What does your Design Control procedure require?

Can you handle this as a design change, i.e. indication/contraindication/user group and environment/performance requirements stay the same? If so, then you'd need to follow your design control/change control procedures and IMHO typically you'd keep the old DHF and just up-date the respective sections regarding design output and design verification&validation with either a new revision or a new doc valid only for GEN2.
If not then it probably would be considered a really new product and you'd develop it acc. to your design control procedure and typically you'd end up with a complete set of documents, where even the ones that have a copy&paste content would at least have to be reviewed again during design review. In that case I personally would not just reference to the doc of the GEN1 DHF...
 

Ronen E

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#3
I work for a med device startup that is still in a development phase. The first generation product (GEN 1) has a well-laid out Design History File (DHF), maintained both in an index and a separate hard copy set of documents, but will not be developed further.

GEN 2 has some significant changes but is basically an evolution of GEN 1. I intend to only maintain an index as keeping a hard copy set seems a waste of time, although the auditors like it.

Should all the documents in the GEN 1 DHF be included in the GEN 2 DHF? There would then be 2 sets of customer requirements, product requirements, user requirements, software development plans, etc. If so, should I identify each document as being for GEN 1 or GEN 2, or both?

I took over this project from my predecessor and did not have input into the first DHF.

Thanks in advance for your help.
I would simply reference GEN 1 DHF index (as a whole) in GEN 2 DHF.

Cheers,
Ronen.
 
#4
First and foremost: What does your Design Control procedure require?

Can you handle this as a design change, i.e. indication/contraindication/user group and environment/performance requirements stay the same? If so, then you'd need to follow your design control/change control procedures and IMHO typically you'd keep the old DHF and just up-date the respective sections regarding design output and design verification&validation with either a new revision or a new doc valid only for GEN2.
If not then it probably would be considered a really new product and you'd develop it acc. to your design control procedure and typically you'd end up with a complete set of documents, where even the ones that have a copy&paste content would at least have to be reviewed again during design review. In that case I personally would not just reference to the doc of the GEN1 DHF...
Aye. do you think all DHFs of your GEN 1 are suitable for GEN2 including all descriptive informaiton in these DHF? If so, i suggest you follow a change control process but not a brand new NPI process.
 
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