About Us / Quality & Regulatory
Quality & Regulatory
Dedicated to Quality
Our medLED® product line is manufactured at our Riverpoint Medical facility in Portland, Oregon USA. Riverpoint Medical is proud of the reputation it has developed as a high quality manufacturer whose self-imposed performance standards exceed the specification requirements of its customers. The company’s Quality System is at the core of our culture and guides our actions in every aspect of our business.
At Riverpoint, we strive to maintain the highest possible quality and product integrity throughout the production process within Class 7 cleanrooms.
- FDA Registered
- ISO 13485: 2016 Certified
- MDSAP Certified
Regulatory Support
At Riverpoint, we can provide products for distribution with FDA clearance & CE marked in 70+ countries. We can also help customers with regulatory support for submissions with technical data.
Quality Management System
Quality Management System certified to the requirements of the international standard ISO 13485 : 2016 and MDSAP for Brazil, Canada, US, Japan, Australia, and EU MDR.
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