Dear Cove
we are certified according ISO13485 as a supplier of components for medical systems (finished medical devices).
Our products are not medical devices!
ISO13485:2012 clause 8.5.1 says: If national or regional regulations require notification of adverse events that meet specific reporting criteria, the organization shall establish documented procedures to such notification to regulatory authorities.
Can we exclude MDR and adverse event reporting/recall procedures from our Quality Manual since our OEM is responsible to report adverse events for medical devices?
Silly question eh?
Thanks for any valuable input.
Cheers
we are certified according ISO13485 as a supplier of components for medical systems (finished medical devices).
Our products are not medical devices!
ISO13485:2012 clause 8.5.1 says: If national or regional regulations require notification of adverse events that meet specific reporting criteria, the organization shall establish documented procedures to such notification to regulatory authorities.
Can we exclude MDR and adverse event reporting/recall procedures from our Quality Manual since our OEM is responsible to report adverse events for medical devices?
Silly question eh?
Thanks for any valuable input.
Cheers