“Smart for today, scalable for tomorrow.”
Here at Congenius, we are well prepared to help start-up companies tackle the challenges involved with gaining 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 system that facilitates compliance with ISO 13485 is a fundamental requirement for achieving certification as a legal manufacturer. Our MDR & IVDR compliant QMS 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 system
tailored to your business
QMgeniuS is a QMS system that can be implemented paper-based or electronically via PDF and digital signature. In close collaboration with your company, one of our experienced consultants builds your system, tailoring it as necessary depending on your company’s needs.
The necessary processes and related documents / templates are scoped and then implemented according to your specific requirements. Our smart solution facilitates your certification in a lean way that saves you time and money.
Request a demoWhat 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 configuration, 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.
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 with no licensing fees for the processes, related documents and templates themselves, our solution is cost-effective – you just pay the consultant fee for tailoring the product and its implementation in line with what your company requires.
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 system 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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