S
s.parakos
This is a somewhat general question regarding the different requirements of the European Medical Device Directive and an ISO 13485 based QMS used to demonstrate conformity to the essential principals of the MDD.
The MDD, unless I am mistaken, is primarily concerned with ensuring that medical devices are safe and all effort has been made to remove/minimize risks to patients or end-users. Fair enough, I say.
ISO 13485 treats safety as one (important) aspect of overall quality. Fair enough too.
However, I should be able to say that the way we do Process X leaves a lot to be desired from a quality perspective but in no way effects the safety of the Device (from risk analysis), and hence we still meet the Essential Requirements of the MDD.
However, if I said that, the QMS would not pass (re)certification, and my Medical Device would not be saleable.
Wouldn't it be appropriate for a Standard based on a subset of ISO 13485 and involved purely with saftey to be used to demonstrate MDD conformity?
An overworked Quality Engineer
Simon
The MDD, unless I am mistaken, is primarily concerned with ensuring that medical devices are safe and all effort has been made to remove/minimize risks to patients or end-users. Fair enough, I say.
ISO 13485 treats safety as one (important) aspect of overall quality. Fair enough too.
However, I should be able to say that the way we do Process X leaves a lot to be desired from a quality perspective but in no way effects the safety of the Device (from risk analysis), and hence we still meet the Essential Requirements of the MDD.
However, if I said that, the QMS would not pass (re)certification, and my Medical Device would not be saleable.
Wouldn't it be appropriate for a Standard based on a subset of ISO 13485 and involved purely with saftey to be used to demonstrate MDD conformity?
An overworked Quality Engineer
Simon