📢 Effective complaint handling is crucial for maintaining the quality and safety of medical devices. Our latest article outlines the process of managing complaints to comply with ISO 13485 and FDA regulations. Discover the importance of proper documentation and investigation to ensure patient safety and product reliability. Read more here: [https://lnkd.in/eweN74kb) #MedicalDevices #QualityManagement #ISO13485
Zamann Pharma Support’s Post
More Relevant Posts
-
Stay ahead in the regulatory game! 📈 In February, the FDA published the QMSR Final Rule, a guideline designed to ensure medical device manufacturers adhere to high standards of quality and safety, promoting harmonization with ISO 13485:2016. Dive into our QMSR overview and discover expert tips on meeting compliance and deadlines. Ensure your success with RookQS as your partner in achieving QMSR compliance! #RegulatoryCompliance #MedicalDevices #QualityManagementSystems #LookToRook
-
Quality standards harmonization in the medical industry is allowing companies to focus more on patient safety and device efficacy. Learn about the harmonization of ISO13485 and FDA Part 820. #qualitystandards #medicaldevices #regulatorycompliance #patientsafety #riskmanagement
-
Navigating FDA compliance can be daunting, but with DP Distribution & Consulting, it doesn't have to be. Here are 3 reasons why you need our expertise to ensure your medical devices meet all necessary standards. Discover how our comprehensive services and experienced team can help you avoid costly penalties and keep your business thriving. Visit https://bit.ly/3UotPwO for more information. #FDACompliance #MedicalDevices #RegulatorySupport #QualityManagement #Consulting #ComplianceExperts #DPDistributionConsulting #FDAAudit #HealthcareRegulations #BusinessSuccess
-
To be ISO 13485:2016 Certified or not ISO 13485:2016 Certified - that is the question...at least when it comes to Quality Management System Regulation (QMSR) success. 😅 Depending on where you fall, your path for medical device regulation may look different to meet the FDA's QMSR standards. In this free whitepaper, Mark Rimbergas, Principal Consultant at Azzur Group, breaks down the key details that medical device manufacturers need to understand to comply with QMSR. https://azzur.co/3wW0JeR #FDA #QMSR #MedicalDevices #RegulatoryCompliance #QualitySystem
-
ISO standards are voluntary. However, they are critical to remaining compliant with regulatory requirements. This is because many ISO are recognised by regulatory bodies such as the FDA, or have been harmonized with Europe regulations. This documents by Greenlight Guru does not include every ISO standard, however, it does include some of the most universal, and important standards for producing safe and impactful medical devices. #ISOStandards #MedicalDevices #MDR #FDA
-
The FDA is aligning 21 CFR Part 820 with ISO 13485, creating the Quality Management System Regulation (QMSR), streamlining requirements for global medical device compliance. Our Medical Device experts can help you align with the new regulations. We're ready now to start working for you. #medicaldevices #iso13485 #fdaqmsr #quality #documentcontrol #meddevice #regulatorycompliance #regulatorychanges
-
-
Holiday deadlines piling up? Don’t let FDA compliance be one of them. At DP Distribution & Consulting, we specialise in helping medical device companies simplify the regulatory process, from FDA registrations to quality management systems. With over 50 years of experience, we’ve supported over 200 clients to ensure compliance and efficiency – all while keeping patient outcomes at the forefront. Let us take the stress out of regulations so you can focus on the new year ahead. Visit www.dpdconline.com to learn more. #FDACompliance #MedicalDevices #QualityManagement #HealthcareInnovation #ISO13485 #NewYearGoals #MedicalDeviceExperts #RegulatoryConsulting #DPDConsulting
-
In case you haven't heard, new medical device quality rules are on the way from the FDA. Stay up to date on the regulations. https://lnkd.in/gfZ3j3GA #FDA #Regulations #compliance #Engineering #qualitysystem #qualitymanagement #MedicalDevice #ManufacturingEngineering #GOASG
-
-
🚨 Important Update for Swiss Authorized Representatives and Importers in Medical Devices 🚨 Swissmedic has sent a letter to Swiss Authorized Representatives and importers, urging a review of medical devices still compliant under the old legislation (MDD/AIMDD). By 📅 26-Sep-2024, it is essential to ensure that all "legacy" devices meet the following requirements: ✅ The manufacturer’s self-declaration under EU MDR Art. 120(3c) ✅ The Notified Body’s confirmation letter Make sure your devices are compliant and avoid potential disruptions. Let’s keep the Swiss medical device market safe and secure! 💪 Stay informed with the latest updates in Regulatory Affairs! Check out RA News here: 👉 https://lnkd.in/eHs3khty #MedTech #Swissmedic #Compliance #EURegulations #MedicalDevices #MDD #AIMDD #MDR #SwissMarket #RegulatoryAffairs
