Product Development & Distribution

Konan Medical USA is an ISO 13485, FDA Registered, MDSAP Certified medical device manufacturer with in-house R&D, Quality Assurance, assembly, logistics, support, sales, and global distribution.

The Company is headquartered in Irvine, California.

In-House Product Development

  • User-interface design

  • Software engineering

  • Micro-code and board design

  • Industrial design / CAD

  • Manufacturing

Global Distribution

  • USA direct sales

  • Global qualified and experienced distribution

Regulatory and Quality Control

  • In-house resources for regulatory filings:

    E.G., FDA, CE Mark, Health Canada, TGA

  • ISO 13484 / MDSAP Quality Control system