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CE Marking for Medical Devices - What Does It Mean?

CE Marking for Medical Devices - What Does It Mean?
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United statesKenneth shawEuropean economic areaEuropean conformityTechnical fileDesign dossierNotified bodyMedical devices regulationVitro diagnostic regulationMedical deviceNotified bodies

Element Science Receives CE Mark & UKCA Mark for the Jewel® Patch-Wearable Cardioverter Defibrillator

Element Science Receives CE Mark & UKCA Mark for the Jewel® Patch-Wearable Cardioverter Defibrillator
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Czech republicSan franciscoUnited statesHank kuchemanUdayn kumarPetr neuBoston scientificElement science incEuropean union medical device regulationAmerican heart associationEuropean unionJewel ep lab studyArrhythmia service at na homolce hospitalPatch wearable cardioverterGreat britainUnited kingdom conformity assessed

Element Science Receives CE Mark & UKCA Mark for the Jewel® Patch-Wearable Cardioverter Defibrillator

Element Science Receives CE Mark & UKCA Mark for the Jewel® Patch-Wearable Cardioverter Defibrillator
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San franciscoUnited statesCzech republicPetr neuUdayn kumarHank kuchemanSharonn buechlerAmerican heart associationJewel ep lab studyEuropean union medical device regulationBoston scientificEuropean unionElement science incArrhythmia service at na homolce hospitalGreat britainUnited kingdom conformity assessed

SGS highlights new IoT cybersecurity regulations coming into force in 2024

Manufacturers and importers of IoT devices should prepare for new regulations coming into force in 2024, advises SGS, the world’s leading testing, inspection and certification company. “With ‘smart’ technology growing exponentially, through televisions, speakers, appliances, locks, exercise trackers and even games, the world is becoming ever more connected,” said Alex Rubert, of SGS Brightsight, the…

United statesUnited kingdomAlex rubertCybersecurity servicesNational institute of standardsUs cyber trust markTelecommunications infrastructureInfocomm media development authorityCheck point researchCalifornia consumer privacy actData protection regulationNational instituteCybersecurity frameworkDemand response standardKingdom product securityTrust mark

ClearPoint Neuro Inc (CLPT) Announces First EU MDR Certification Success and Approval to Ship Product to Europe

ClearPoint Neuro Inc (CLPT) Announces First EU MDR Certification Success and Approval to Ship Product to Europe
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United statesMegan faulkenberryClearpoint neuro incClearpoint neuroEuropean medical device regulationNotified bodyMedical device regulationMedical device directiveVice president