PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE (PRRC)
A Person Responsible for Regulatory Compliance (PRRC) is required for Swiss Authorized Representative (CH-REP) according to the Medical Devices Ordinance (MedDO). The Authorized Representative shall have permanently and continuously at their disposal at least one PRRC.
The role and responsibilities of the PRRC are various from Regulatory Affairs to Quality Management System (QMS) compliance as follow:
To implement cost effective and compliant solution, do not hesitate to mandate PMSystem as contracted PRRC (e. g. part time representative function) for your company.