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Are you prepared for the upcoming EU Medical Device Regulation (MDR) transition deadline on May 26th, 2024? #Compliance is not just important; it's legally mandated. But worry not - PBC Biomed are here to help! By May 26th 2024, all manufacturers *must* have applied for #MDR certification with an MDR notified body or, before their current Medical Device Directive (MDD) certificate expires. Otherwise, the device will no longer qualify as a 'legacy device' under the extension and subsequently cannot be placed on the market. Additionally, a signed contract with an MDR notified body will need to be in place before 26th September 2024. Unsure if your devices qualify for the extension? Contact our team today at info@pbcbiomed.com for more information on how we can support you meet MDR transition timelines. #regulatory #EUMDR #MDD #pbcbiomed #acceleratingmedicalinnovation

Very important changes- PBC Biomed can help with this transition.

Hey everyone, Darren here with another DP Minute. In today’s segment, we dive into the discussions surrounding Comment No. 26 from the QMSR Preamble. This comment highlights reactions from the medical device industry regarding the FDA’s proposed definitions of terms already established in ISO 9000:2015. The community’s feedback was clear, suggesting the FDA should adopt these existing definitions rather than reinventing the wheel. Watch the video to see how the FDA responded, and how that impacts those in the medical device manufacturing field. If you need more support regarding medical device regulations, visit us at DPDConline.com. Let's also connect here on LinkedIn to continue the conversation. #MedicalDeviceRegulation #FDA #ISO9000 #QMSR #MedicalDevices #MedicalDeviceRegulatoryConsulting #DPDConsulting

In the intricate landscape of regulatory compliance, whether introducing a new device to the EU market or transitioning a legacy device, manufacturers are confronted with the complexities of the Medical Devices Regulation (MDR). Importantly, legacy devices are not grandfathered in; instead, they must undergo a transition of their CE certificates in accordance with MDR requirements. Achieving compliance with the MDR demands a concerted effort, dedicated time, and substantial resources to meet its stringent requirements. At MedEnvoy, we understand the intricacies of this regulatory landscape and are well-equipped to assist manufacturers at every step of the compliance process. For comprehensive details about our services and how we can facilitate your compliance with the MDR, please click here: https://lnkd.in/gCuCn-Mw #MDR #EUMDR #medicdaldevice

Team-NB members adopted a common paper aimed at describing in detail the pre-application and application and Post application phases processes through which manufacturers may apply to Notified Bodies (NBs) for the certification of medical devices under the regulation (EU) 2017/745 (MDR). https://lnkd.in/eBqhWYPp

Discover how strategic PMCF surveys can drive compliance and innovation in the medical device industry. Dive into our latest case study where we provided comprehensive EU MDR support for a Class III legacy device, showcasing our tailored approach and impactful results. A must-read for professionals navigating regulatory landscapes! Read the full case study https://lnkd.in/dcAqVXNZ #medicaldevices #regulatorycompliance #casestudy #eumdr #mdrregulation

A must-read for professionals navigating regulatory landscapes! Read the full case study https://lnkd.in/dcAqVXNZ #medicaldevices #regulatorycompliance #casestudy #eumdr #mdrregulation

The FDA recalled over 900 medical device models in 2022, representing a 125% increase in recalls since 2014. Are you comfortable that you have the documentation of reasonable due diligence from your organization to ensure the devices that are in use are compliant and accurately inventoried? #medicaldeviceinventory #soraai #aiinhealthcare #recalls

Dive into the latest regulatory updates impacting medical device manufacturers! On March 15, 2023, EU amended the MDR and IVDR, extending transitional periods for compliance. Discover how these changes affect you and how NPG can help navigate them seamlessly.  💡 Learn more in our latest blog post: https://lnkd.in/dSbYPP7m. Stay ahead with NPG’s expert guidance on EU MDR compliance! #MedicalDevices #RegulatoryCompliance #EU #MDR #IVDR #Healthcare #NPG

Team-NB adopted a common paper to submit application describing pre-application, application and Post application phases processes through which manufacturers may apply to Notified Bodies (NBs) for the certification of medical devices under the regulation (EU) 2017/745 (MDR). More info: https://lnkd.in/eBqhWYPp