Comprehensive
& Straightforward

QMgeniuS provides you with a basic framework for establishing a complete QMS according to ISO 13485 with a simple setup, catering to your individual needs as a start-up. With the same methodology utilised for each of the processes, our intuitive system is easy to understand and easy to implement.

Our eQMS solution provides a user-friendly environment in which your documentation is stored digitally and can be reviewed and released via digital workflows. And when it comes to updating the processes or templates in the eQMS as your company evolves, you’ll only need to upload your updated documentation – there’s no need to reconfigure the electronic system itself, as is usually required for more complex eQMS solutions.

If a digital solution doesn’t fit your needs, our paper-based execution provides a manageable alternative for start-ups with a smaller budget.

Lean
& Compliant

Whilst our system is simple enough to suit small infrastructures, our regulatory expertise ensures up-to-date compliance with ISO 13485 as well as the EU MDR and EU IVDR as required, and our eQMS is fully validated, including accordance with 21 CFR Part 11 (Electronic Records / Signatures).

Digitally managing your records, processes, and templates, our eQMS focuses just on the essentials, providing an efficient middle ground between a basic paper-based solution and a full Business Process Modelling system.

The annual licence fee for our eQMS solution is cost effective and includes full support and change requests. And should our paper-based solution better suit your requirements, the only cost is the consultant fee for tailoring the processes and their implementation in line with what your company needs.

Adaptable
& Scalable

Together, we start by creating your Management Handbook to identify what your company requires in terms of processes. Then collaboratively, we tailor the processes as necessary depending on the needs of your company.

It’s our job to then empower you to train your team on the implementation of your processes as you prepare for certification. The foundation we help you to lay is scalable – the QMS / eQMS we create together can be adapted as your company grows and evolves.

Transparent
& Trustworthy

QMgeniuS is a proven solution that’s been formed from in-house experience and executed with many customers – it doesn’t rely on a third party. We introduce the base system, then build and tailor the final system together with you. Your assigned Congenius Consultant will help you at every step of scoping, creation, and implementation, so you benefit from over a decade of knowledge and experience.