“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.Request a demo
QMgeniuS – Our 5 step QMS solution
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.
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.
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.
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.
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.
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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