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Nu-Med Plus, Inc. Approaches Landmark Certification to Speed New Nitric Oxide Medical Device Approval
Innovative Nitric Oxide Delivery Device Company Announces Program to Attain ISO 13485 Certification
SALT LAKE CITY, July 31, 2018 (GLOBE NEWSWIRE) -- Nu-Med Plus, Inc. (OTCQB:NUMD), a medical device leader developing new nitric oxide delivery technology along with innovative applications in the medical field, announces the launch of a new program to attain ISO 13485 certification. The announcement comes in anticipation of near-term FDA 510(k) fillings for Nu-Med Plus nitric oxide delivery 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 of Nu-Med Plus Inc., “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.”
ISO 13485 is an international standard that specifies requirements for a quality management system for design, development and manufacture of medical devices. The current administration recently published regulatory reform plans that harmonize FDA regulations with international standards. This will make medical devices approved in the U.S. easier to approve in other countries. Nu-Med Plus management has recognized the significance of these changes and is proactively taking steps to make Nu-Med Plus devices available for the international market.
Nu-Med Plus, Inc. is a medical device company created to develop new nitric oxide delivery technology and focus applications on high growth-potential markets where a clearly defined need has been recognized by the medical community. Initial research and product development has been in the delivery of inhaled nitric oxide gas for therapeutic use.
ISO 13485 Certification will be conducted by a reputable and independent third party. Certification is expected to be issued late in the fourth quarter of this year. Nu-Med Plus management has already launched a quality management systems program. Companywide training has been completed, creation of documents and systems are underway.
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About Nu-Med Plus, Inc.: Nu-Med Plus, Inc. founded in 2011 is a medical device development company created to explore medical applications of newly developed nitric oxide technologies. The strategy is to focus on high growth potential markets where there is a clearly defined need recognized by the medical community that can be addressed by Nu-Med Plus and its technical expertise. Initial research and product development has been in the delivery of inhaled nitric oxide gas for therapeutic use. For more information please visit www.nu-medplus.com.
Forward-Looking Statements: Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. These statements reflect management's current estimates, beliefs, intentions and expectations. They are not guarantees of future performance. The Company cautions that all forward looking statements are inherently uncertain, and that actual performance may be affected by a number of material factors, many of which are beyond the Company's control. Such factors include, among other things: risks and uncertainties relating to the Company's ability to complete proposed private placement financing. Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Except as required under applicable securities legislation, the Company undertakes no obligation to publicly update or revise forward-looking information.