Quality & Regulatory

Dedicated to Quality

You’ll rest easy knowing that Riverpoint Medical has developed a reputation as a high-quality manufacturer with self-imposed performance standards that exceed the specification requirements of its customers. Our Quality System is at the core of our culture and guides our actions in every aspect of our work.

Your patient safety and security are definitely our business. Our entire team strives to maintain the highest possible quality and product integrity throughout the production process within Class 7 cleanrooms.

Quality & Regulatory
  • 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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