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.
Key Highlights:
- Regulatory Compliance: DoseMeRx, which previously held a Directives Certificate under the Medical Device Directive (MDD), has now submitted a formal application for CE certification under MDR ensuring continued market presence and regulatory compliance.
- Patient Safety: The submission of our MDR application to the notified body reaffirms our dedication to patient safety and the effectiveness of our precision dosing software.
- Uninterrupted Service: Our customers can be confident that DoseMeRx will continue to deliver reliable and precise dosing recommendations, with no interruptions or disruptions in service.
- Enhanced Standards: The MDR introduces more rigorous standards for medical devices, and DoseMeRx’s compliance with these standards highlights our ongoing efforts to improve patient outcomes and healthcare efficiency.
“As an Authorized Representative in the EU working with DoseMe, we recognize this is a significant milestone and underscores DoseMe’s commitment to maintaining the highest standards of safety, quality, and regulatory compliance,” States Rene Van De Zande, Partner and CCO, MedEnvoy Global, Inc. “DoseMe customers, both existing and prospective, will continue to rely on DoseMeRx with the assurance that it meets the stringent requirements of the MDR.”
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 Conformité Européenne certification, which is French for "European conformity".
“We are thrilled to have successfully navigated the transition to the MDR framework,” said Paul Edwards, CEO, DoseMe. “This 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.”
About DoseMe
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
About MedEnvoy Global, Inc.
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.
https://medenvoyglobal.com/about-us/
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Contacts
Alison Guzzio
aguzzio@dosemehealth.com
484-459-3243
