Your ISO 13485 QMS – hassle free, immediately available and with individual support and training.
The perfect fit for every medical device manufacturer.
Medical Device and In vitro Diagnostics Medical Device manufacturers shall implement a QMS and others, such as CMOs, CH REP, Importer, Distributor, can align their procedures to ISO 13485 for regulatory compliance.
Instead of writing a proprietary QMS with high upfront costs, a pre-written QMS in accordance with ISO 13485 can be rented as “Quality as a Service” (QaaS) without the need to refrain from tailoring the QMS to the client’s needs.
Rent-a-QMS includes all modules of ISO 13485 pre-populated in an electronic Document Management System (eDMS), securely managed on certified European Servers only. The Rent-a-QMS includes:
Define your specific content and needs on top of the eQMS modules
Implement the specific content yourself or by us within our Service proposition
Train your staff via the built-in training module with full flexibility and traceability
Fully validated and compliant DMS without the need for extra modules.
Pre-validated according to ISO 13485 and can be customized if needed or the company grows
No need for additional modules, training for the QMS and the DMS as well the training module itself is included
The pre-populated QMS allows companies to start immediately by getting trained and implementing the procedures
Fully certified TIER IV European servers only, without mirroring or backup elsewhere
Simple monthly payment eases the budget and let's plan ahead with the possibility to scale any time
