S
Re: Post-Market Surveillance required by the EU’s MDD vs. ISO 13485 requirements
As Al and I (and the MDD) have indicated, the post-market surveillance is for your own products. I think the problem is that, other than anecdotal evidence (e.g. from sales staff, medical device related forums etc), how difficult it is to get direct feedback from customers/users in the first place. It is all very well saying use surveys – but how many surveys have you been sent that just end up in the bin (trash)! Auditors must know this – so is this just a tick the box game they must play?
Steve
As Al and I (and the MDD) have indicated, the post-market surveillance is for your own products. I think the problem is that, other than anecdotal evidence (e.g. from sales staff, medical device related forums etc), how difficult it is to get direct feedback from customers/users in the first place. It is all very well saying use surveys – but how many surveys have you been sent that just end up in the bin (trash)! Auditors must know this – so is this just a tick the box game they must play?

Steve