person responsible for regulatory compliancePlease define PRRC.
Hi
Just wanted to check - I'm assuming that there is no reason why the PRRC couldn't be the same person as the Management Representative?
Thanks
James
Read thru the requirements for PRRC. If the requirements are fulfilled, there's no reason why the MR can't be the PRRC. Just remember to document the appointment either through JD (Job Description) or Appointment Letter depending on the your company system.Hi
Just wanted to check - I'm assuming that there is no reason why the PRRC couldn't be the same person as the Management Representative?
Thanks
James
Regarding requirements for PRRC as per article 15:
does ISO 9001 count as QMS related to medical devices in relation to
"at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices; "?