“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 demo
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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