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Adapting your processes to meet changing requirements can be a costly business, being part of a collaboration with your industry colleagues can help you take a measured and accurate approach! #biophorum #mediphorum

The FDA have recently published a final rule to implement a Quality Management System Regulation (#QMSR), which aligns the US quality system requirements for medical devices with the international ISO 13485:2016 standard.    It details the implications for manufacturers and the steps they need to take to ensure compliance by the 2026 implementation deadline.     Read our latest article to learn more about the background and implementation timeline, key changes and clarifications, and the impact on manufacturers and #FDA operations. 👇   Our medical device experts are here to help you understand the implications of this publication.    To discuss your requirements, email our award-winning regulatory team at hello@dlrcgroup.com. #MedTech #MedicalDevices #RegulatoryAffairs

If you are seeking answers on how to align with the #FDA #QMSR, we can assist you. Read our article below for more guidance and get in touch at hello@dlrcgroup.com

Check out this insightful update on FDA’s new quality management system regulations from DLA’s fabulous FDA team!

Bethany Hills Grois, JD/MPH, Christopher M. Mikson, MD, JD, Perham Gorji, Jae Kim, Adam Donat, Marco de Morpurgo and Ting Xiao share an exciting update from the FDA on medical device manufacturing regulations. Learn about the recent amendments to the Quality System Regulation (QMSR) aligning with ISO 13485:2016 and key takeaways for industry players. #FDA #MedicalDevices #RegulatoryChanges

The FDA has finalized the Quality Management System Regulation (QMSR). Harmonizing the FDA's quality management requirements with the globally recognized ISO 13485 standard will streamline regulatory compliance for medical device companies, including those developing innovative new technologies in eye care. This update brings welcomed consistency across international regulatory regimes. While we are still evaluating the specifics of the new rule, we believe it will reduce duplicative regulatory burdens and facilitate bringing novel ophthalmic devices to market more efficiently.   As partners to medtech firms in advancing eye care, we look forward to collaborating under the new QMS framework to continue delivering impactful research that benefits patients.   #ophthalmology #clinicalresearch #ophthalmicdevices #innovation True North Contract Research Read more here: https://lnkd.in/dbznjRK2

Our CEO is on top of it! The FDA Quality Management System Regulation (QMSR) Final Rule has arrived. Keep an eye on our page for in-depth guidance following the final publication. As always, reach out to us at MedLark with questions or assistance in maintaining your QMS. We’d love to hear from you! #meddevice #fda #qualitymanagement #medicaldevice #qualitycompliance

In short, FDA's harmonization of its device quality management system regulations with ISO 13485:2016 will help to further the establishment of a global standard for device quality systems, but it will have little practical effect on the quality systems and compliance efforts of medical device companies #medicalit

Getting your medical devices cleared or approved through the FDA is an ever-changing challenge. On January 31, 2024, the FDA announced the long-awaited publication of the new Quality Management System Regulation (QMSR) with formal publication to occur on February 2, 2024. The QSMR is the result of merging the current Quality System (QS) Regulation, which is also known as current Good Manufacturing Practice (cGMP), with the international standard ISO 13485:2016. The QSMR will be an amendment to 21 CFR 820. The QSMR aims to bridge differences between QS regulation and ISO 13485:2016 with emphasis on risk management activities and risk-based decision making throughout all quality management system (QMS) processes.   This merging together of FDA and ISO requirements is most welcome and should lead to less confusion when it comes to understanding and implementing FDA's expectations. Manufacturers who sell medical devices in the U.S. will have until 2nd February 2026 (two years from publication) to modify their QMS and, until then, are required to maintain compliance with the QS Regulation.   Let the experience of ERI Group guide you to success. Contact ragroup@erigroup.com to see how we can help. #QSRegulation info: https://lnkd.in/ePRzasd9 #fdaapproval #fdacompliance #fdaregulations #qms #eqms #qmsr

It’s here! The FDA is publishing the Quality Management System Regulation (QMSR) Final Rule on 2Feb2024! The Final Rule amends the current cGMP and 21CFR820 rules for medical devices, incorporating aspects of ISO 13485:2016, which most of us in the industry are very familiar with at this point. The publication is a big step for FDA, as it is more in line with what we are seeing internationally, as well as supporting FDA’s participation in the MDSAP program. You may be wondering, “What does the publication mean for me?” 1️⃣ Keep an eye out for the final publication in the coming days. 2️⃣ Follow us at MedLark, as we will be back with an in-depth comparison of the changes to the current 21CFR820 landscape. 3️⃣ Maintain your compliance with 21CFR820, as it will remain in effect until February 2, 2026. As always, feel free to reach out to us at MedLark with questions or assistance in maintaining your QMS. We’d love to hear from you! #meddevice #fda #qualitymanagement #medicaldevice #qualitycompliance