Dear community,
I recently started my career in the fields of Regulatory Affairs for a software as a medical and am responsible for the Technical Documentation.
Getting familiar with the most important standards such as 62304, 13485, 14971 and 62366 was definitely intense and there's certainly many things I don't know 100%.
Therefore, I lack some knowledge and have a few questions regarding more regular updates e.g.
For example, I wonder how exactly the decision whether a document for a newly released version of our medical device is done. E.g. most of the clinical evaluation and post market surveillance documents should face no update if there's more frequent software updates, right? They can just be left untouched whereas probably the Instruction for Use will probably always need updates alongside with software requirements, tests etc.
Certainly, the Technical Documentation has to be kept up-to-date alongside with product updates.
However, carefully updating everything and leaving no gaps at all slows down the process of releasing significantly and I am very interested about opinions whether or not it is too risky and "reckless" to sometimes leave gaps and don't update certain documents that are deemed "not essential".
There's definitely also different opinions at my job because of people who are way more careful than I wish I could act.
The questions I always ask myself are: are patient's endangered if I don't update this and will this cause a major non-conformity?
Because I feel like those should be the goals if you work in a working environment with a high pressure.
Sorry for the long explanation but I find regulatory work quite challenging though very interesting. Maybe someone can really pinpoint a section in the MDR or another standard regarding the update of documents? I also know that in some articles, there is explicitly stated e.g. "at least annually PSUR" or sth. But that doesn't apply for every document that needs to be part of the Technical Documentation, as far as I know.
I recently started my career in the fields of Regulatory Affairs for a software as a medical and am responsible for the Technical Documentation.
Getting familiar with the most important standards such as 62304, 13485, 14971 and 62366 was definitely intense and there's certainly many things I don't know 100%.
Therefore, I lack some knowledge and have a few questions regarding more regular updates e.g.
For example, I wonder how exactly the decision whether a document for a newly released version of our medical device is done. E.g. most of the clinical evaluation and post market surveillance documents should face no update if there's more frequent software updates, right? They can just be left untouched whereas probably the Instruction for Use will probably always need updates alongside with software requirements, tests etc.
Certainly, the Technical Documentation has to be kept up-to-date alongside with product updates.
However, carefully updating everything and leaving no gaps at all slows down the process of releasing significantly and I am very interested about opinions whether or not it is too risky and "reckless" to sometimes leave gaps and don't update certain documents that are deemed "not essential".
There's definitely also different opinions at my job because of people who are way more careful than I wish I could act.
The questions I always ask myself are: are patient's endangered if I don't update this and will this cause a major non-conformity?
Because I feel like those should be the goals if you work in a working environment with a high pressure.
Sorry for the long explanation but I find regulatory work quite challenging though very interesting. Maybe someone can really pinpoint a section in the MDR or another standard regarding the update of documents? I also know that in some articles, there is explicitly stated e.g. "at least annually PSUR" or sth. But that doesn't apply for every document that needs to be part of the Technical Documentation, as far as I know.