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With the QMSR's final rule now in effect, it's time to get your organization in motion! That’s why we’re hosting a FREE webinar session where we'll dive deep into navigating the FDA's QMSR final rule with Scilife. Event details: 🗓️ April 24, 2024 | ⏰ 11h (CET) Live! We’ll cover how: - Scilife's Document Control solution streamlines QMS process determination and ensures alignment with regulatory requirements. - Scilife's Change Control solution records and assesses changes in processes and medical devices seamlessly. - Scilife's KPIs solution enables comprehensive process monitoring, measurement, and analysis for improved quality management. If you’re in the life sciences, it’s vital to stay ahead of the curve in understanding the implications of QMSR and ensuring compliance. We understand how overwhelming you may feel, and don't worry—we've got you covered. 🔗 Register for free: https://hubs.li/Q02qpb9F0 Spread the word and tag your colleagues who can't afford to miss this! Let's master the QMSR final rule together! #QMSR #FDA #Compliance #LifeSciences #RegulatoryChanges #QualityManagement

Interested in how the Laboratory Developed Tests, known as In-House Devices in the EU, are regulated in the US and EU? While there are many differences, there are also some foundational similarities. Both are moving towards more oversight and holding LDTs to similar requirements as other IVDs, including: - QMS implementation based on ISO 13485 - Submissions for highest risk products with a phased approach for lower risk products - Enforcement discretion or exemptions for LDTs for unmet needs integrated in the healthcare system. How Quarem Can Help: - Free initial consultation - Expert quality and regulatory guidance - Portfolio assessment - Technical documentation - Quality management system implementation Stay tuned for more on how the FDA LDT Final Rule is being challenged in the United States.

For IVD labs and companies providing diagnostic results to patients in the EU and US, the FDA LDT Final Rule and the IVDR will have a profound impact on how LDTs are regulated. #LDTs #IVD #Medicaldevices #Regulatory #Quality #Diagnostics #Compliance #FDA #IVDR

🌟 Dive deep into the world of quality standards with our latest blog post on the Excellence Gurus website! 📝✨ Unravel the mysteries surrounding ISO 9001 and ISO 13485 as we break down their distinct differences. 💡 From quality management to regulatory requirements, this blog post is your comprehensive guide to understanding the nuances between these two essential standards. Whether you're a seasoned professional or new to the field, this is a must-read for anyone striving for excellence in their organization. Click the link below to embark on this enlightening journey with us! 🚀🔍 https://lnkd.in/d7vH5k7H #excellencegurus #excellence #quality #iso #medicaldevices

The Shift from QSR to QMSR: What Life Science Companies Need to Know The FDA's transition from the Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR), set for February 2, 2026, is a game-changer for the life science industry. Unlike QSR, which focuses on specific procedural controls, the new QMSR framework fully aligns with ISO 13485:2016 standards, bringing a global approach to quality management. For life science companies, this shift emphasizes a risk-based approach to product lifecycle management, increased documentation, and heightened supplier controls. The harmonization with ISO means that companies can streamline regulatory processes for both U.S. and international markets, potentially easing global market access and reducing compliance burdens across regions. Now is the time for companies to conduct a Gap Assessment to identify steps needed to meet the new QMSR requirements. Avendium specializes in Gap Assessments to help life science organizations align with QMSR standards, ensuring they’re ready for the regulatory shift. Reach out to us to understand what your company needs to be QMSR-compliant and stay ahead in quality and innovation. #QualityManagement #FDARegulations #QMSR #LifeSciences #ISO13485 #Compliance #MedicalDevices

https://lnkd.in/gSbjhEnN (link to QMSR Gap Analysis Checklist) For some medical device companies transitioning from the current FDA QSR to the QMSR and ISO 13485:2016 requirements could be challenging, and involve significant changes to their quality management system. It is highly recommended to follow these 4 transition process steps. For every company the required changes and time to implement will be different and these are general periods to be adjusted to match specific company needs. This is all part of the benefits of conducting a detailed gap analysis and implementation plan: 1) Obtain copies of the QMSR, ISO 13485:2016 and, supporting Standards. Read and understand the detailed requirements. 2) Complete a Gap Analysis between the current QMS and the QMSR and ISO 13485:2016 requirements. From this info develop a transition plan. 3) Implement the required QMS changes. 4) Plan to operate with the revised QMS for 9 to 12 months to provide enough time to conduct internal audits and make any required corrective actions. Also, time to accumulate records to show evidence of full compliance. Keep in mind when making changes during this transition period that full compliance with the current QSR is required up until the QMSR becomes effective on Feb. 2, 2026. Looking for assistance with your QMSR transition, contact us through email, or LinkedIn message and we can start a discussion. #fdaqmsr #iso13485 #gapanalysis #qualitymanagement #qmsrtransitionhelp

Is your company ready for the transition from QSR to QMSR. If you are working with the FDA review the video below to help get you prepared as we move into a new stage in early 2026.

📢 Don't miss our webinar on June 06 📅 Sylvain Chamouton invites you to join us for 1 hour of training and discussion on implementing an ISO 13485 quality management system for medical device manufacturers.   The implementation of a quality management system according to ISO 13485 is a crucial step for any medical device manufacturer aspiring to operational excellence and regulatory compliance. This international standard establishes the requirements for a quality management system that can be used by an company involved in one or more stages of the life cycle of a medical device. ISO 13485 focuses on risk management and the development of safe and effective medical devices. It covers aspects such as resource management, product development, and continuous improvement. The implementation of this standard requires a deep understanding of its requirements, as well as careful planning and preparation. As part of this process, medical device manufacturers must establish, document, implement, and maintain a quality management system and ensure its effectiveness in accordance with the requirements of ISO 13485. 👉 Here's the registration link https://lnkd.in/eFZHCr2F 📧 For any information contact us at: [email protected]

The FDA’s new Quality Management System Regulation (QMSR) is here! Published on January 31, 2024, and effective February 2, 2026, this regulation marks a significant shift in how medical device companies must operate. Our new blog series is designed to guide you through the transition. Our first article breaks down the changes and provides practical steps to help your company comply. Don't wait until it’s too late—start preparing now. Read the first post in the series today! 👉 https://lnkd.in/eqD38nWT #MedicalDevices #QMSR #QualityManagement #FDACompliance #RegulatoryAffairs #ComplianceArchitects