Rent-a-QMS

Your ISO 13485 QMS – hustle free, immediately available and with individual support and training.

The perfect fit for every medical device manufacturer.

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.

What is included

Rent-a-QMS includes all modules of the ISO 13485 pre-populated in an electronic Document Management System (eDMS), securely managed on certified European Servers only. The Rent-a-QMS includes:

QMS according to ISO 13485 for general Medical Devices in English or German (additional languages will follow)
Tailoring the QMS procedures and templates to the clients’ specific needs
Access to the eDMS including the modules for Training Management, CAPA, PMS, Change Management, Forms
Training of the eDMS
Training of the eQMS