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Stereotaxis receives CE mark certification for devices in Europe

Stereotaxis Inc. recently received CE mark recertification for all its devices currently available in Europe under the new Medical Device Regulation (MDR) regulatory framework. The MDR has replaced the European Medical Device Directive and includes more stringent standards but meeting the new requirements comes with frustrations and costs for many companies.

Stereotaxis incMedical device regulationEuropean medical device directive

Stereotaxis Receives CE Mark Recertification Under EU s MDR Regulatory Framework

Stereotaxis Receives CE Mark Recertification Under EU s MDR Regulatory Framework
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United statesDavidl fischelKimberlyr peeryDavid fischelStereotaxis incEuropean unionCompany contactsExchange commissionGlobenewswire incRegulatory affairsMedical device regulationEuropean medical device directiveManagement systemStereotaxis quality systemNotified bodyChief executive

Neoss® Group receives EU Medical Device Regulation (MDR) certifications for implants and abutments

Neoss® Group receives EU Medical Device Regulation (MDR) certifications for implants and abutments
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Vastra gotalands lanRobert gottlanderFredrik engmanNeoss groupEuropean unionNeoss group quality management systemPrnewswire neoss groupDevice regulationNotified bodyNeos quality management systemClassi reusableQuality management systemDevices regulationEuropean medical device directive

ROKIT HEALTHCARE Achieves European Certification for Cutting-Edge Organ Regeneration

ROKIT HEALTHCARE Achieves European Certification for Cutting-Edge Organ Regeneration
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Soult ukpyolsiSouth koreaSeoul national university hospitalKorean ministry of foodEuropean economic communityEuropean unionGlobal centreEuropean certificationCutting edge organEuropean medical device regulationSouth korean ministryDrug safetyEuropean medical device directiveHwan youDasan hospital

Form 10-K IRADIMED CORP For: Dec 31

Form 10-K IRADIMED CORP For: Dec 31
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