Contact US

Manufacturer News NeoMed gets FDA approval for product line, achieves ISO 13485:2003 certification

NeoMed Inc (Woodstock, GA) announced 510(k) clear­ance from the FDA (Rockville, MD) of its line of sterile oral/enteral syringes. The new sterile oral/enteral syringes comple­ment NeoMed’s lines of clear, amber and bulk phar­macy pack oral dispensers. NeoMed also received a certi­fi­ca­tion for the successful regis­tra­tion of its quality manage­ment system for sterile feeding tubes, exten­sion sets, syringes, umbil­ical vessel catheters, and urinary drainage catheters to both the ISO 13485:2003 stan­dard, and the require­ments of the Canadian Medical Devices Conformity Assessment System (CMDCAS). The Canadian Medical Device Regulations require compli­ance with ISO 13485:2003 as well as regu­la­tions specific to Canada.