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Your ISO 13485 QMS – hassle 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 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.

What is included

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:

3 simple steps to your eQMS

Step 1


Define your specific content and needs on top of the eQMS modules

Step 2


Implement the specific content yourself or by us within our Service proposition

Step 3


Train your staff via the built-in training module with full flexibility and traceability

Document Management System

Fully validated and compliant DMS without the need for extra modules.

Quality Management System

Pre-validated according to ISO 13485 and can be customized if needed or the company grows

Support and Training

No need for additional modules, training for the QMS and the DMS as well the training module itself is included

Immediate Start

The pre-populated QMS allows companies to start immediately by getting trained and implementing the procedures

Server Security

Fully certified TIER IV European servers only, without mirroring or backup elsewhere

Monthly Payment

Simple monthly payment eases the budget and let's plan ahead with the possibility to scale any time


Save up to CHF 70’000.- by using Rent-a-QMS!

Your monthly fee within the first 24 months:

CHF 0.-

Your monthly fee after 24 months:

CHF 0.-

Receive your quote by email

Rent-a-qms is a product of Avanti Europe.