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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:

Document Management System

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Quality Management System

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Support and Training

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Immediate Start

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Server Security

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Monthly Payment

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Our Pricing

The pricing is compiled of a tailoring fee and a user access fee

User access fee

1-5 user: CHF 99.- /per month /user

6-10 user: CHF 79.- /per month /user

11-20 user: CHF 59.- /per month /user

more than 20 user: Companies with 20+ users will have special pricing upon request.

Tailoring fee for the first 24 months

Manufacturer: CHF 1’699.- / month

Authorized Reps: CHF 1’299.- / month

Importers: CHF 999.- / month

Distributors: CHF 500 / month

Tailoring fee 24+ months

Manufacturer: CHF 500.- / month

Authorized Reps: CHF 500.- / month

Importers: CHF 500.- / month

Distributors: CHF 500 / month

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