Business
Net Medical Expands COVID Services With Clinical Trials for Manufacturers
Net Medical Expands COVID Services With Clinical Trials for Manufacturers.
About this update from Net Medical Xpress Solutions, Inc.
[{"type":"text","content":"Leaning on two decades of experience connecting providers with the patients who need them, Net Medical's business is unique and growingALBUQUERQUE, NM / ACCESSWIRE / April 4, 2022 / Net Medical (OTC PINK:NMXS) announced today it has launched a clinical trial program for medical device manufacturers needing to file an Emergency Use Authorization (EUA) or a 510K clearance with the FDA.International as well as domestic medical manufacturing companies that want to sell products in the U.S. market are required to file either an EUA or obtain a 510K FDA clearance. An EUA is effective until the circumstances justifying the authorization of the emergency use are terminated by the FDA. At that point, companies must obtain a 510K FDA clearance in order to continue to sell their products.With the powerful combination of the Net Medical's proprietary Telemed software, a CLIA authorized laboratory and a highly specialized lab staff, Net Medical is particularly well-equipped to implement this program.Net Medical's Telemed software placed third in the FDA's Designathon contest for COVID-19 reporting in December 2020 out of 731 competing participants including some of the world's best-known companies. This was an important verification and endorsement of the depth and power of Telemed. https://bit.ly/3K6rOxpNet Medical CEO Dick Govatski said, "With the deep COVID expertise we have acquired over the past two years, Net Medical has developed a highly complex service essential for medical manufacturers to work through a rigorous process of compliance and regulatory hurdles. Telemed provides highly specific data acquisition, management, maintenance and reporting in English and Spanish. As part of the enforcement policy for medical devices under EUA requirements, manufacturers must follow the reporting (MDR) requirements established in 21 CFR Part 803 (Code of Federal Regulations)."There are few companies like ours able to handle these requirements because of the power of Telemed that enables running clinical trials requiring extensive processing and reporting of complex interrelated activities. We've integrated our telemedicine platform plus a laboratory information system serving the point of care market and the over-thecounter markets. This enables our system to deal with existing and growing Federal regulations and reporting requiremen...