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.
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.