GF Health Earns ISO 13485:2016 and MDSAP Certification in U.S. Locations

The medical device manufacturer says the certification will allow for more growth in the market and improved efficiency.

• By Haley Samsel
• Oct 14, 2019

GF Health Products has achieved ISO 13485:2016 and MDSAP certification for six of its U.S. locations, the company announced last week. 

The ISO certification is given to an organization that demonstrates its ability to provide medical devices and related services that “consistently meet customer and applicable regulatory requirements,” according to the FDA. In addition, GF Health also passed the MDSAP audit, which indicates that the manufacturer’s quality management system satisfies regulations.

“We are extremely proud of our employees’ efforts as this certification provides a critical building block for our continued growth in the medical device market and is yet another example of our ongoing dedication to quality,” Cherie L. Antoniazzi, GF Health’s senior vice president of quality, regulatory and risk management, said in a statement.

GF Health CEO Ken Spett added that the certifications give his company a competitive advantage, as well as the potential for better operational efficiency and productivity. He added the certification is an “achievement that all of our employees can take pride in accomplishing.”