“Smart for today, scalable for tomorrow.”

Here at Congenius, we are well prepared to help start-up companies tackle the challenges involved with gaining device certification within the highly regulated MedTech industry. We understand that as a company taking your initial steps onto the market, you need to build a solid QMS foundation that will support the enhancement of your core business.

Establishing a reliable QMS that facilitates compliance with ISO 13485 is a fundamental requirement for achieving device certification as a legal manufacturer. Our MDR & IVDR compliant QMS / eQMS solution for start-ups is based on robust experience and validated approaches, providing you with direction and reassurance as you look to make your mark on the industry.

A QMS tailored
to your business

QMgeniuS is a QMS that can be implemented electronically (eQMS) through a digital Document Management System (DMS) or via a paper-based execution.

User-friendly and easy to maintain, our digital solution involves creating and managing your Word and Excel processes, templates, and records using check-in / check-out revision control or collaboratively within a SharePoint environment on a simple digital DMS platform.

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QMgeniuS – Our 5 step QMS solution

Step 1

In close collaboration with your company, the necessary processes and related templates are scoped and then implemented within Word and Excel according to your specific business requirements. We’ll then help you to decide whether our eQMS or our paper-based QMS is most suitable for your needs.
Step 2

If you opt for our paper-based solution, the next and final step involves printing your documentation and wet signing, then training your team on how to operate the QMS.

For our eQMS solution, Step 2 involves setting up your electronic system (tailoring it as necessary depending on your company’s needs) and incorporating the functionality to safely store your documentation in the digital environment, including review and release of your documentation via digital workflows. At this point we introduce the system to your team members tasked with managing the system ongoing.
Step 3

Following testing and validation of the electronic system according to 21 CFR Part 11, the necessary processes and related templates are uploaded and released according to your specific requirements.
Step 4

We then run through an introduction to your system with your wider team, training your team on its functionality, and how to operate the QMS.
Step 5

Naturally, once your company has had time to settle into the new eQMS solution, areas for modification to improve efficiency may be identified, so we also provide support for any necessary system adaptations.

Whether you opt for our simple eQMS or our paper-based QMS, our smart solution facilitates your certification in a lean way that saves you time and money.

What are the benefits?

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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.

Get in touch

If QMgeniuS sounds like a solution that could help your business, please do get in touch.

You can start the conversation by requesting a demo below. And should you have another Quality-related challenge, take a look at our range of services provided by our Congenius Quality Consultants.

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QMgeniuS

A QMS tailored
to your business

QMgeniuS – Our 5 step QMS solution

Step 1

Step 2

Step 3

Step 4

Step 5