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DoseMeRx Submitted a Formal Application for CE Certification Under MDR, Ensuring Uninterrupted Service and Safety for Customers and Patients

DoseMeRx Submitted a Formal Application for CE Certification Under MDR, Ensuring Uninterrupted Service and Safety for Customers and Patients
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De zandeStates rene vanPaul edwardsAlison guzzioMedenvoy global incEuropean union eu medical device regulationUninterrupted serviceDirectives certificateMedical device directiveAuthorized representativeRene van de zandeMedenvoy globalEuropean unionMedical device regulationDoseme analyticsIhr portfolio

ZOLL Medical Corporation: ZOLL One of the First to Receive Approval for AEDs Under the EU Medical Device Regulation (MDR) Certification

ZOLL Medical Corporation: ZOLL One of the First to Receive Approval for AEDs Under the EU Medical Device Regulation (MDR) Certification
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EU continues struggle with rollout of new device regs in 2023

Regulation of medical devices is always a messy and complicated task, but that has proven to be particularly true of the European Union’s (EU) Medical Device Regulation (MDR). Thanks largely to problems with the capacity of notified bodies (NBs) to review renewals of existing CE marks, patients in the EU may experience a significant dearth of medical devices over the next couple of years, a nightmare scenario that has all stakeholders scrambling for solutions.

European union eu medical device regulationEuropean unionMedical device regulationFace markNotified bodies

Effective Clinical Evaluation Preparation Enables EU Mdr Compliance

Effective Clinical Evaluation Preparation Enables EU Mdr Compliance
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Femasys Inc EU MDR Final Audit Successfully Completed

– Completion of the European Union Medical Device Regulation final audit is the last step in obtaining an MDR certificate and CE marking, confirming Femasys’ compliance with the highest required.

United statesFemasy femaseedFemasy femblocChuck padalaKathy lee sepsickAmerica incDrug administrationAuditing organizationEuropean union eu medical device regulationEuropean unionEuropean union medical device regulationLifesci advisorsFemasys incMedical device regulationUnited states foodDevice directive