🚨 Adverse event reporting isn't just paperwork—it's critical for patient safety and compliance. 🚨 Do your lab teams understand their responsibilities when it comes to FDA reporting requirements? Tara Cepull, MA, breaks down what every lab leader needs to know. 🧪 Don’t leave compliance to chance—click to uncover the essentials: https://bit.ly/40TOa0o #LabCompliance #FDARegulations #PatientSafety
G2 Intelligence’s Post
More Relevant Posts
-
As we continue inching closer to the Phase 1 enforcement rollout of the FDA’s oversight of #LDTs, there is a lot that #labs may need to do to prepare. This includes understanding how and when to report adverse events and creating a process for doing so. Check out my piece below, which offers some really helpful information, especially for labs that will be reporting #adverseevents to the #FDA for the first time. Special thanks to experts Julie Ballard and Darrin Carlson, RAC-Devices, PMP for their insights. #medicallaboratoryscience #laboratorydevelopedtests #labdirectors #CLIA #IVD #healthcare #writing #editing #contentcreation
🚨 Adverse event reporting isn't just paperwork—it's critical for patient safety and compliance. 🚨 Do your lab teams understand their responsibilities when it comes to FDA reporting requirements? Tara Cepull, MA, breaks down what every lab leader needs to know. 🧪 Don’t leave compliance to chance—click to uncover the essentials: https://bit.ly/40TOa0o #LabCompliance #FDARegulations #PatientSafety
-
-
Stay up to date on the latest regulatory quality assurance, and safety information in this week's Friday Five. Key reads include: Acknowledgement of World Patient Safety Day, IPG Mentorship and Integration Project, and a Renewal Reminder. To read it now click here: https://lnkd.in/gaTCRjgn #PharmacyStandardsMB #PharmPDEvents
-
-
When a program sponsor changes, research doesn't have to stop. A strong CRO can handle the challenges and ensure that regulatory compliance, patient safety, and data integrity are maintained: https://bit.ly/4dUnboD #ClinicalResearch #CROExpertise
-
-
Not even a week into 2025, and we’re already treated to an MDCG Guidance update! ⁉️ 🧾 While revision 2 brings only minor updates since the last revision in October 2024, it’s still a great reminder to revisit this essential guidance document on vigilance. 📝 Covering both MDR and IVDR, the guidance provides clear definitions and practical examples of key vigilance concepts—an invaluable resource for ensuring compliance and enhancing patient safety. 💭 Have you reviewed the guidance recently? What are your thoughts?
-
Medical Device Regulatory Consultant | Turnkey Project, CDSCO registration, Indian FDA, CE MDR , 510(k), MDSAP, SFDA, UKCA, ISO 13485, ISO 15378 | Medical Device Consultant
Ensure safety, quality, and performance across the entire medical device lifecycle 🛠️✅. From concept to post-market surveillance, align risk management, clinical evaluation, and biocompatibility 🔍💡. Continuous evaluation guarantees the device meets its intended purpose 🎯. Trust a holistic approach for regulatory success and patient safety 🏥👩⚕️. https://lnkd.in/djirTF6d #MedicalDeviceStrategy #LifecycleAlignment #PatientSafety #RegulatoryCompliance #QualityAssurance #Biocompatibility #RiskManagement #MedicalInnovation #DevicePerformance #HealthcareExcellence
-
-
During challenging times, the path to patient safety starts with Datwyler, because we put care, quality, and drug integrity first. https://bit.ly/4cj9XAV
-
Technical Lead at Operon Strategist | Medical Device Turnkey Project | US FDA | ISO 13485 Consultant
Ensure safety, quality, and performance across the entire medical device lifecycle 🛠️✅. From concept to post-market surveillance, align risk management, clinical evaluation, and biocompatibility 🔍💡. Continuous evaluation guarantees the device meets its intended purpose 🎯. Trust a holistic approach for regulatory success and patient safety 🏥👩⚕️. https://lnkd.in/ez7hbAGx #MedicalDeviceStrategy #LifecycleAlignment #PatientSafety #RegulatoryCompliance #QualityAssurance #Biocompatibility #RiskManagement #MedicalInnovation #DevicePerformance #HealthcareExcellence
-
-
Founder and CEO @ Medical Device Regulatory and Turnkey Project Consultant | Operon Strategist
Ensure safety, quality, and performance across the entire medical device lifecycle 🛠️✅. From concept to post-market surveillance, align risk management, clinical evaluation, and biocompatibility 🔍💡. Continuous evaluation guarantees the device meets its intended purpose 🎯. Trust a holistic approach for regulatory success and patient safety 🏥👩⚕️. https://lnkd.in/e4GPhV4B #MedicalDeviceStrategy #LifecycleAlignment #PatientSafety #RegulatoryCompliance #QualityAssurance #Biocompatibility #RiskManagement #MedicalInnovation #DevicePerformance #HealthcareExcellence
-
-
Ensure safety, quality, and performance across the entire medical device lifecycle 🛠️✅. From concept to post-market surveillance, align risk management, clinical evaluation, and biocompatibility 🔍💡. Continuous evaluation guarantees the device meets its intended purpose 🎯. Trust a holistic approach for regulatory success and patient safety 🏥👩⚕️. https://lnkd.in/eTKNFWvv #MedicalDeviceStrategy #LifecycleAlignment #PatientSafety #RegulatoryCompliance #QualityAssurance #Biocompatibility #RiskManagement #MedicalInnovation #DevicePerformance #HealthcareExcellence
-
