Nu-Med Plus Inc. (NUMD:OTC.MKTS) began the process of obtaining ISO 13485 certification ahead of filing for U.S. Food and Drug Administration approval of its nitric oxide delivery devices. ISO 13485 is a set of international standards for designing, developing and manufacturing medical devices.
"This is a significant undertaking that we plan will pay off with faster approval of our nitric oxide delivery devices by the FDA," says Jeff Robins, CEO. "With the FDA moving toward international harmonization of standards, we believe this strategic move will position Nu-Med for growth in the international markets as well."
Indeed, Nu-Med aims to ultimately sell its products globally.
With respect to the certification requirements, the company has, to date, established a quality management systems program and trained its personnel on it. Currently, it is establishing and documenting additional processes.
Once completed, an independent, third party will determine whether or not Nu-Med has successfully met the necessary conditions. If the company has, it could be granted ISO 13485 certification in Q4/18.
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