Ingen Technologies, Inc. a leading Global Medical Device manufacturer focused in the $8 Billion global Respiratory Market for the growing ageing populations and emerging markets for Home (DME), Hospital and Aviation Industries announced today that they have signed agreements yesterday with Emergo Global Consulting LLC to prepare and register the required ISO and CE Mark certifications to market and sell Oxyview in Europe, Asia and Canada.
Emergo Group has become the authorized representative for medical devices and will produce the required technical file compilation for CE Mark compliance, and the quality system implementation in accordance with quality system requirements for ISO 13485:2003, CE Marking (Annex II or V), Canadian Medical Device Regulations and FDA Good Manufacturing Practices (GMP).
Emergo Group is an ISO registered medical device consulting firm with offices in the United States, Canada, Europe, China, Japan and Australia. By focusing on providing outstanding customer service and value for their clients, Emergo Group has grown to become one of the leading medical device regulatory consultants with expertise in CE Marking, Good Manufacturing Practices (GMP), ISO 13485 quality system implementation, Canadian licensing, China SFDA registration, Japanese device approval, in-country representation and many other areas.
Ingen Technologies’ Oxyview product is required to meet the International Standards Organization (ISO requirement (ISO-13485) to be sold in China, Canada and the European Community. The company has distribution in China and Canada, and has pending contracts with several large distributors, such as Nidek Medical in Asia. The agreements between the company and Emergo Group require approximately $40,000 in fees and 3-4 months in preparation and filing to complete the ISO and CE Mark certifications.
The company has recently brought current their filings responsibilities with the SEC and Pink OTC Markets, as well as announced the new introduction of the Oxyview-Cannula that includes a partnership with Legend Medical Devices, Inc. “The respiratory markets outside of the U.S. represent even a better market for Oxyview and this market is now very receptive in wanting to purchase our Oxyview product. We have recently been issued a patent in China, and we have patents pending that are near being issued in Japan and the European Communities. We are well financed, and are moving full steam ahead with our growth plans,” stated Scott Sand, Chief Executive Officer of Ingen Technologies.
Source: Ingen Technologies Inc.