Yes, that´s why I´m asking this.
Thanks a lot for your input.
Can i ask you some question to clarify some points?
- 7.4.1 - is it not easily applicable (meaning, you have difficulties applying the requirement) or is the only problem is that the procedure required is not used very often (and thus seems like a document burden, but can be easily implemented)?
- 7.5 - I can understand the problem you have, but not the link to the standard. Which clauses are you referring to? Can you give some example?
- 8.x - yeah, that´s a very interesting point, and it´s a complex interaction. You will really need to make a strong link to IEC 62304. But it isn´t again very clear to me, I don´t in principle see any problems because the general requirements of ISO 13485 can accommodate any other more detailed requirement, for example of IEC 62304 (at least this is the idea). I would say that it does require a lot of work, but not that it is problematic. Or have you noticed something really problematic, meaning, you needed to remove an ISo 13485 requirement due to a requirement of IEC 62304 or something like that?
Again, thanks for all your feedback!