Matrix Requirements’ Post

The European Union’s Medical Device Regulation (MDR) has set new benchmarks for safety and efficacy, revolutionizing the regulatory landscape. However, its implementation has brought significant challenges, especially in resource allocation. These hurdles can stretch your regulatory teams thin, impacting your time-to-market and operational efficiency. A mid-sized medical device company successfully transitioned to MDR compliance with Qserve’s interim support, reducing time-to-market and achieving certification for several products. Discover how Qserve can assist you in managing MDR challenges effectively: ➡ https://lnkd.in/eKFFMNXt. #medicaldevices #interimsupport #MDR

Medical Devices – USA, Europe, Asia and ROW Regulatory News – Mar. 2024 Stay updated on the latest medical device regulatory changes from USA, Europe, and Asia in our March 2024 roundup. Read more: https://lnkd.in/gxhr29hJ #Compliance #GlobalHealth #HealthPolicy #HealthcareIndustry #MedicalDevices #MedicalTechnology #Regulations #RegulatoryUpdates

🚨 **Major Update in Medical Device Regulation!** In the rapidly evolving world of medical devices and diagnostics, staying informed is key. The European Commission’s Medical Device Coordination Group (MDCG) has recently raised concerns over the low number of applications for the new MDR and IVDR certifications. 🔍 We've delved deep into the latest developments, including extended transition periods and crucial amendments aimed at preventing shortages and ensuring patient safety. 👉 Why should you be concerned? The changes affect manufacturers and healthcare professionals alike, posing challenges and opportunities in the MedTech industry. ➡️ Read our detailed analysis on these critical updates in our latest blog post. It's a must-read for anyone in the medical device field to stay ahead of the curve.   #MedicalDevices #MDR #IVDR #MedTech #HealthcareRegulation #EuropeanCommission

Post-market clinical follow-up (PMCF) plays an essential role in the product life cycle of a medical device, which many manufacturers only realised with the introduction of the Medical Device Regulation (EU) 2017/745 (MDR). PMCF helps to continuously monitor and improve the clinical performance and, above all, the safety of medical devices even after their market launch. This important process is based on various methods, best practices and regulatory requirements that every manufacturer should be familiar with. #PMCF #regulatoryaffairs #clinicalaffairs #MDR #seleon #regulatoryaffairsBlog #Blog #regulatory #medicaldevices #ProductLifeCycle

In March 2023, transition periods were extended for the EU MDR. But the European Commission urges those impacted to "...take advantage of the delay by making absolutely sure that you will be ready for the new deadline." So, as a #MedicalDevice manufacturer, what do you need to know? Explore our article to get answers to the questions: ◾ What is the European Medical Device Regulation? ◾ How are medical devices classified under EU MDR? ◾ When are the transition period and compliance deadlines? ◾ What are the impacts of the European MDR? ◾ What is the role of notified bodies? ◾ How can medical device manufacturers prepare? https://bit.ly/46nFuj1

In this months column in Today's Medical Developments Magazine we discuss the EU Medical Device Regulation (MDR), a comprehensive set of cumbersome regulations being implemented throughout Europe for MedTech companies wishing to do business in the EU. Read our column to learn five major reasons these EU MDR regulations have potential drawbacks for Europe’s patients and why they may ultimately result in benefits for patients in the U.S. MedWorld Advisors Today's Medical Developments Magazine GIE Media, Inc. Dave Sheppard, CMAA Florence Joffroy-Black CMAA #medworld #mdr #medicaldeviceregulation #eumdr #medtech #meddevice #medicaldevice #healthcare

MDCG a guidance updated !!

Stay ahead in the dynamic world of medical device regulations with John Thomas! Discover vital insights on clinical investigation exemptions for Class III and implantable devices under the EU MDR in this overview of his OCT Medical Devices EU presentation: https://bit.ly/48rrRPV #MedicalDevices #EUMDR #RegulatoryInsights

EUDAMED is a comprehensive, centralized digital platform designed to store and maintain crucial information about medical devices circulating in the EU market. It is a key element in complying with the EU’s MDR and IVDR, as registering their devices in #EUDAMED is a mandatory step toward EU market authorization.   Learn more about EUDAMED and its role in EU Medical Device Regulation from our blog post:

The European Medical Device Regulation (MDR) is a cornerstone of the medical device industry in Europe. Transitioning from the Medical Device Directive (MDD) to the MDR has presented challenges, especially for smaller and medium-sized enterprises (SMEs). Olga emphasized the importance of the CE Mark, a certification that indicates conformity with European standards. With over 60 global geographies leveraging the CE Mark, its significance cannot be understated. https://lnkd.in/ewNGf_qG #lifesciences #medicaldevices #healthcare