Jupiter, FL \u2013 May 30, 2024<\/p>\n\n\n\n
DoseMe, a leading provider of model-informed precision dosing (MIPD), is pleased to announce that its flagship product, DoseMeRx, has filed the necessary application for a CE certificate with the notified body for MDR Conformity, ahead of the May 26, 2024, deadline.<\/p>\n\n\n\n
Key Highlights:<\/p>\n\n\n\n
\u201cAs an Authorized Representative in the EU working with DoseMe, we recognize this is a significant milestone and underscores DoseMe\u2019s commitment to maintaining the highest standards of safety, quality, and regulatory compliance.\u201d States Rene Van De Zande, Partner and CCO, MedEnvoy Global, Inc., \u201cDoseMe customers, both existing and prospective, will continue to rely on DoseMeRx with the assurance that it meets the stringent requirements of the MDR.\u201d<\/p>\n\n\n\n
CE certification under the European Union’s (EU) Medical Device Regulation (MDR) 2017\/745 is a mandatory conformity marking that indicates a medical device meets the EU’s safety, health, and environmental protection standards. It’s also known as Conformit\u00e9 Europ\u00e9enne certification, which is French for \u00abEuropean conformity\u00bb.<\/p>\n\n\n\n
\u201cWe are thrilled to have successfully navigated the transition to the MDR framework,\u201d said Paul Edwards, CEO, DoseMe. \u201cThis achievement not only demonstrates our commitment to regulatory excellence but also ensures that our customers and their patients remain protected under the latest European medical device regulations. Our team has worked diligently to meet these requirements, and we are proud to continue providing a safe and compliant solution.\u201d<\/p>\n\n\n\n
DoseMe combines smart technology with science, leveraging clinically-validated PK\/PD models, patient characteristics, drug concentrations, and genotype to accurately individualize a dose in seconds. The platform is HIPAA, ISO & FDA compliant and the only Bayesian dosing platform to be HITRUST CSF certified. For more information on successful applications of its products, DoseMeRx and DoseMe Analytics, visit https:\/\/doseme-rx.com\/success-stories<\/a><\/p>\n\n\n\n Established in the Netherlands by experienced and reputable regulatory affairs executives, MedEnvoy is a fast-growing company. We take pride in being a minority-owned company dedicated to promoting diversity and inclusion. Our goal is to ensure our clients maintain more control over regulatory compliance and their commercial activities. We achieve this by merging the roles of In- Country Representative and Regulatory Importer. To effectively assume both roles, we maintain high levels of organization, possess comprehensive regulatory expertise, and hold ourselves to the same standards as the clients we serve, including being ISO 13485 certified. Mira c\u00f3mo DoseMeRx trabaja y se integra en tu rutina de trabajo diaria.<\/p>\n Solicita una demo a continuaci\u00f3n. Puedes telefonearnos al +1 (832) 358-3308<\/a>\u00a0o email\u00a0hello@dosemehealth.com<\/a>.<\/p>\n<\/div>\t\t\r\n\r\nAbout MedEnvoy Global, Inc.<\/h3>\n\n\n\n
https:\/\/medenvoyglobal.com\/about-us\/<\/a><\/p>\n\n\nSolicita una demo<\/h2>\r\n\t