More than just a QMS
Medical Device and In vitro Diagnostics Medical Device manufacturers shall implement a QMS and others, such as CMOs, CH REP, Importer, Distributor, can align its procedures to ISO 13485 for regulatory compliance.
Instead of having written a proprietary QMS with high upfront costs, a pre-written QMS according to ISO 13485 can be rent without the need to refrain from tailoring the QMS to the clients needs.