QR Wise
A Partner for Expansion
No matter where in the world you might want to go with your novel medical product – we are ready to be your regulatory and quality partner.
✓ Are you a medical device entrepreneur / manufacturer?
✓ Do you have your sights set on expansion in an overseas market?
We provide efficient solutions for FDA, CE, and NMPA licensing.
Our Focus
Strategy
When you choose us, you’ll be sure that we will first talk about strategy. You need to understand the regulatory framework and pathways needed to get where you want to be. We will start by giving you an overview and a plan, always keeping your company goals in mind.
Quality Management
Most companies need a quality management system set up, but not all. If your company needs it, we can set it up for you, get it certified and provide the necessary training to your staff.
Perfection
Any submission to a regulatory body must be perfect. This is the main part of our commitment to you – we will scrutinize your designs, its developments, and the deliverables for submission like no one else.
Execution
Our professional team will manage and execute your project from beginning to end so that you can focus on what you do best: providing the best possible active medical device to your new target audience.
Troubleshooting
As you progress towards market clearance, developmental delays and submission issues will most probably arise. We have been called the ‘real time’ experts – and not for nothing! With QR Wise, you can rest assured that we will stay on top of any RA/QA challenge so that we can get your device approved as quickly as possible.
Some of Our Clients
Clients Recommendations
