QRx Partners’ Post

Navigating Regulatory Landscapes! Stay informed and ensure regulatory compliance with Quality Means Business. Visit https://www.qmbdevices.com to learn how we can help you navigate through your specific regulatory needs! #RegulatoryAffairs #quality #QualityMeansBusiness #artificialintelligence #machinelearning #fda #EMA #compliance

https://lnkd.in/eDYryFHn Finding challenges with Regulatory Compliance and Process Standardisation? Discover How QbD’s Advanced QMS Can Revolutionise Your Strategy! Message me for more ℹ️ #LeadWithQuality #RegulatoryRevolution #InnovatePharma #QMSLeadership #QualityManagement #RegulatoryCompliance #PharmaInnovation #QMSExcellence”

I am excited to share that I have gained the new certification from Regulatory Affairs Professionals Society (RAPS) for Regulatory Compliance Certification - MDR (RCC-MDR). Very proud to have achieved this internationally recognised accreditation! #raps #regulatorycompliance #mdr #regulatoryaffairs #mdrcompliance #accreditation

The path to FDA compliance is complex, requiring meticulous attention to regulatory changes and quality management principles. DP Distribution & Consulting offers unparalleled support in this journey, providing services that range from quality management systems to comprehensive FDA investigation preparations. Our role transcends that of a typical consultant; we see ourselves as your strategic partners, committed to ensuring your success in the regulatory landscape. Let's discuss how we can tailor our services to meet your unique challenges: https://bit.ly/3UotPwO #DPDConsulting #FDACompliance #QualityManagement #RegulatorySupport #FDAudit #MedicalDeviceConsulting #PartnersInCompliance #RegulatoryNavigators #HealthcareCompliance #MedicalDeviceSuccess

What should I be doing this year to navigate the new FDA Ruling on LDTs? The FDA's recent updates to the regulatory framework for Laboratory Developed Tests (LDTs) mark a significant shift in how diagnostics are developed and utilized in the healthcare sector. As we step into the first year of compliance, it's crucial to strategically align with these new regulations. Here’s what you need to start doing this year 1.    Understand the Regulation: Begin with a thorough review of the new FDA guidelines to understand the scope and specifics of what compliance entails. 2.    Gap Analysis: Assess your current processes and identify gaps in compliance with the new regulations. This can involve everything from test development to data reporting. 3.    Develop a Compliance Plan: Based on your gap analysis, create a detailed action plan that addresses all areas of non-compliance, with timelines and responsibilities clearly defined. 4.    Training and Awareness: Ensure that your team is well-informed about the changes and understands their roles in supporting compliance. 5.    Engage with the FDA: Early and ongoing engagement with the FDA can provide clarifications, assist in smooth transition, and help mitigate potential compliance risks. Pro Tip: Start with a consultation with us or other quality and regulatory experts who can offer guidance tailored to your specific needs and help streamline your compliance journey. For more insights on staying ahead in regulatory compliance, follow us! #FDA #Healthcare #Compliance #LDTs #RegulatoryAffairs #QualityAssurance #LifeSciences

Data integrity issues can occur for many reasons, and your QMS can be impacted negatively, leading to potential FDA actions.   This makes creating a well-defined QMS a critical necessity to make sure your quality procedures are completed correctly and leave no room for either intentional or unintentional errors.   IQVIA Quality Consulting can help you identify and remediate any data integrity issues, and learn how to prevent them in the future with GMP focused strategies to create a stronger culture of quality.   Learn more in the article below. #medicaldevices #medtech #qualityassurance #compliance

🚀 Regulatory news from #USFDA! The #USFDA has just revamped its #CGMP requirements of the #QSR, incorporating #ISO13485 to bring forth the Quality Management System Regulation (#QMSR). This move not only aligns with global standards but also harmonizes quality management system requirements. 💡 Check out the QMSR here: https://shorturl.at/foE67 📅Published on 02 Feb 2024, the QMSR will take effect on 02 Feb 2026. RegTrac provides regulatory partner & support services for #medicaldevices and #invitrodiagnostics. Get in touch with us to schedule a 30-minute consultation with our experts at info@reg-trac.com | www.reg-trac.com #MedicalInnovation #HealthTech #FDAUpdates #QualityManagement #ISO13485Compliance #HealthcareStandards #MedicalDevices #PatientSafety #regulatoryaffairs #regulatoryupdates #regulatoryexcellence #regulatorychanges #regulatoryupdate #regulatoryintelligence #regulatoryinsights #regulatorysubmissions #regulatorystandards #regulatoryrequirements #regulatoryframework #regulatoryscience #regulatorystrategy #regulatorychallenges #regulatorytechnology #regulatorychange #regulatoryreporting #regulatoryapproval

Big News from FDA 📯 Final rule amending the 21 CFR part 820 of the US Quality System Regulations to incorporate #iso13485 has been released, giving rise to the QMSR. This move leads to the harmonization of GMP requirements, and is aimed to reduce the regulatory burdens of the MD manufacturers. However, the FDA "does not" mandate ISO 13485 certification for medical device manufacturers, and it will "NOT" use ISO 13485 certificates as a basis for regulatory oversight. ISO 13485 certificates will not substitute FDA oversight processes, such as inspections under section 704 of the FD&C Act or the generation of an EIR. Also, FDA inspections will not lead to the issuance of a certificate of conformity to ISO 13485. Check the below post to know more! #fda #fdaapproval #fdacompliance #fdaregulations #qms #us #regulatoryaffairs #regulation #iso #standard #requirement #certification #conformityassessment #medicaldevices #manufacturer

For the "intent" of producing safe and effective medical products, a comprehensive and functionally aligned QMS has been shown to be a most effective pathway. We have to think beyond "compliance" to the regulations for the sake of passing audits. It is important that we understand and recognize the value and intent of the regulations. #medicalproducts #QMS #compliance #regulatory #meddevices