K
KoD_RP
Hi All,
I am working on a software house certified under ISO 13485:2012.
We have developed a product under these regulations. A customer now asks for the DHF document, which is not required for 13485.
1. Do you know whether the IEC32604 requires a DHF document?
2. Is there a template available just to get an idea?
3. Is there a correlation between 13485 procedures and the "Design control".
Frankly, I am a bit confused.
4 How do I track different versions of the some document?
5. We have a web based reporting system where the customer can report bugs/changes etc. Based on the request, we update SDS documents, perform test reports etc. Do we have to record the web based entries as well in the DHF?
Any help will be highly appreciated!
Paul
I am working on a software house certified under ISO 13485:2012.
We have developed a product under these regulations. A customer now asks for the DHF document, which is not required for 13485.
1. Do you know whether the IEC32604 requires a DHF document?
2. Is there a template available just to get an idea?
3. Is there a correlation between 13485 procedures and the "Design control".
Frankly, I am a bit confused.
4 How do I track different versions of the some document?
5. We have a web based reporting system where the customer can report bugs/changes etc. Based on the request, we update SDS documents, perform test reports etc. Do we have to record the web based entries as well in the DHF?
Any help will be highly appreciated!
Paul