RE: Worth a listen9 Nov 2024 11:37
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.