Quality Standards
   

Martech® Medical Products is an FDA Registered Medical Device Manufacturer and ISO 13485:2003 registered company. All facilities comply with all FDA QSR and ISO requirements for manufacturing medical devices. Martech® Medical has an experienced Regulatory Department that can assist with all phases of international product approvals, including FDA 510(k) and PMA, EU-CE, Canadian Licensing, and Japanese Shonin.

LINKS FOR MORE INFORMATION:
ABOUT FDA QSR

ISO OVERVIEW