The medical device industry is highly regulated, but with RegNav. we make it easier for manufacturers and innovators to navigate the complex regulatory process. RegNav identifies the safety and performance requirements, creating a comprehensive plan that increases confidence in the submission for medical devices. Have you already identified your applicable standards? Let RegNav verify it for you with a free gap analysis. Find out more about our plan options here. https://ow.ly/JRKz50SpvHA #MedicalDeviceIndustry #RegulatoryCompliance #MedicalDeviceManufacturing #FDACompliance #HealthcareRegulations #MedicalDeviceExperts #CompliancePlan #elelementregnav #regnav
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Finally, a way to be confident in your medical device regulatory journey. RegNav helps to save time, effort, and complications from the start with our unique online tool developed by our principle medical device experts. Already identified what standards you think are applicable? Use RegNav Verify for a free assessment of your compliance plan to assist with determining if you have found all applicable standards. Clear your path to compliance with RegNav. Try It Here https://ow.ly/T7ZJ50SNbx9 #RegulatoryCompliance #MedicalDevices #MedTech #RegulatoryAffairs #ComplianceSimplified #DeviceRegulation #RegulatoryGuidance #SimplifyCompliance #ElementRegNav #RegNav
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Attention…. If you’re planning a medical device regulatory submission or simply doing an internal audit of your strategy for regulatory compliance take a look at our new ‘verify’ service. Have the chance to input your medical device product intended purpose and technological characteristics to see whether or not the essential principles and standards you intend to apply are in line with the generally acknowledged state of the art. Ideal for NPI project managers, compliance and regulatory professionals and auditors to ensure that you are focussed on the right requirements. You never know ‘verify’ may help you avoid or anticipate a Notified body or FDA question. Element RegNav try it out!!! #medicaldevicedesign #medicaldeviceinnovation #FDA #EUMDR #Notifiedbody #medicaldeviceauditing #Medicaldevicemarketaccess #ISO13485 #ISO14971 #ISO10993 #IEC60601 #IEc80601
Finally, a way to be confident in your medical device regulatory journey. RegNav helps to save time, effort, and complications from the start with our unique online tool developed by our principle medical device experts. Already identified what standards you think are applicable? Use RegNav Verify for a free assessment of your compliance plan to assist with determining if you have found all applicable standards. Clear your path to compliance with RegNav. Try It Here https://ow.ly/T7ZJ50SNbx9 #RegulatoryCompliance #MedicalDevices #MedTech #RegulatoryAffairs #ComplianceSimplified #DeviceRegulation #RegulatoryGuidance #SimplifyCompliance #ElementRegNav #RegNav
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Are you attending RAPS Convergence 2024? Visit Element Materials Technology booth 642 and just ask for Kim Lipman to see how the RegNav tool identifies product-level requirements for medical devices faster than ever before! #RAPS2024 https://ow.ly/ejIY50TljA1 #RegulatoryCommunity #RAPSConference #Regulations #Compliance #HealthcareRegulation #MedicalDevices #RegulatoryAffairs #RegulatoryCompliance #ElementMaterialsTechnology #ElementRegNav #RegNav
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Learn from our experts how the new Medical Device Regulation (MDR) affects medical suppliers and manufacturers serving their customers, and the importance of counting on a supplier that clearly understands this new regulation. Visit our website to learn more: https://ow.ly/ROMR30sAcYL #MedicalDeviceRegulation #MDR #MedicalSolutions
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If you are a start-up medical device company facing time constraints and struggling with navigating complex regulatory requirements, RegNav offers a simplified process to bring your lifesaving or life-enhancing product to market. Explore it yourself and schedule a Demo today! 📅https://ow.ly/xxzZ50SWNJA #MedicalDeviceRegulations #InnovationForGood #RegulatoryCompliance #MedicalDeviceIndustry #RegulatoryAffairs #MedDevice #FDACompliance #ElementRegNav #RegNav
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The regulatory landscape for #medtech in the EU is complex, continuously evolving, and challenging to navigate. Assess your readiness for the transition to Medical Device Regulation with this preparedness checklist: https://lnkd.in/efxku9Vj #medicaldevices #MDR
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Learn from our experts how the new Medical Device Regulation (MDR) affects medical suppliers and manufacturers serving their customers, and the importance of counting on a supplier that clearly understands this new regulation. Visit our website to learn more: https://ow.ly/xE2j30sAc3g #MedicalDeviceRegulation #MDR #MedicalSolutions
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Learn from our experts how the new Medical Device Regulation (MDR) affects medical suppliers and manufacturers serving their customers, and the importance of counting on a supplier that clearly understands this new regulation. Visit our website to learn more: https://ow.ly/UCpz30sAcU2 #MedicalDeviceRegulation #MDR #MedicalSolutions
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Dear followers, the Commission has published "COMMISSION IMPLEMENTING DECISION (EU) 2024/2120 of 30 July 2024 renewing the designation of issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices". This decision provided for the designation of issuing entities for Unique Device Identifiers (UDIs) in the field of medical devices until 2029. These issuing bodies will provide manufacturers with the UDIs to be assigned. Source: https://lnkd.in/ewaB-v_b #UDI #medicaldevices #uniquedeviceidentifiers #europeancommission #traceability #qualityassurance #regulatoryaffairs #vlfconsulting
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Learn from our experts how the new Medical Device Regulation (MDR) affects medical suppliers and manufacturers serving their customers, and the importance of counting on a supplier that clearly understands this new regulation. Visit our website to learn more: https://ow.ly/TYLo30sAbgx #MedicalDeviceRegulation #MDR #MedicalSolutions
