Independent Consultant (MD-IVD) for MDQMS & Regulatory Compliances (CDSCO-Licensing, CE, USFDA, MDSAP). WHO-PQ Consultant, Trainer, Assessor 17021 Investor, Entrepreneur. Author. Cook,
#Change_Management is an Art in #MDQMS. www.intrust-consulting.com has made it easier. #Medical_Device #IVD [email protected]
💡 Structured Dialogues with TÜV SÜD Post market clinical follow-up (PMCF) ensures the long-term safety and performance of a device already on the market. While clinical data is usually necessary to obtain a CE-mark, it's crucial to continuously monitor the device's safety and performance. 📄 PMCF studies allow manufacturers to proactively address specific questions and better understand how a device performs, unlike a vigilance system which can only be reactive. 👉 Want to find out more? Our clinical team consists of 40 experts covering most medical specialties allowing for a complete in-house assessment and certification of your medical device. Get in touch with our experts today! http://spkl.io/6048fRaqC #TUVSUD #MDR #IVDR #medicaldevices
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How are you currently performing these critical clinical trial functions? IXRS®3 is the only patient randomisation and supply management platform to offer Sponsors novel IRT products to centralise these disjointed functions into a single platform. Replace bulky or outdated processes with transparent and instantly compliant IRT add-ons and see the immediate time and cost-saving benefits. Learn more: https://okt.to/hgw2rn #clinicaltrials #IRT #supplymanagement
How are you currently performing these critical clinical trial functions? IXRS®3 is the only patient randomisation and supply management platform to offer Sponsors novel IRT products to centralise these disjointed functions into a single platform. Replace bulky or outdated processes with transparent and instantly compliant IRT add-ons and see the immediate time and cost-saving benefits. Learn more: https://okt.to/IGpm3E #clinicaltrials #IRT #supplymanagement
Clinical Software Specialist at Rockingham County Rehabilitation and Nursing Center
ICYMI: Manual 📝systems lead to inefficiencies and errors in med 💊 management that strain pharmacy workflows and directly impact resident wellness💖. Learn more about how @PointClickCare is addressing these challenges. #WTWPCC
ICYMI: Manual 📝systems lead to inefficiencies and errors in med 💊 management that strain pharmacy workflows and directly impact resident wellness💖. Learn more about how @PointClickCare is addressing these challenges. #WTWPCC
Physical Therapist Assistant at Hillcrest Care Center and The Towers & Wray Community District Hospital
ICYMI: Manual 📝systems lead to inefficiencies and errors in med 💊 management that strain pharmacy workflows and directly impact resident wellness💖. Learn more about how @PointClickCare is addressing these challenges. #WTWPCC
Regulatory Affairs & Quality Assurance | MDSAP & ISO 13485 Certified | Specializing in SaMD & Business Development | Empowering Medical Device Companies in the Healthcare Industry
🚨 Enhancing Global Adverse Event Data Exchange for Medical Devices 🚨 The International Medical Device Regulators Forum (IMDRF) has just released the final version of its Common Data Set (CDS) for Adverse Event Data Exchange. This milestone is a significant step toward harmonizing adverse event reporting across regulatory authorities, enhancing global public health safety. With this CDS, regulators worldwide can more efficiently detect trends, validate safety signals, and respond swiftly to medical device incidents. Building on past frameworks like the GHTF N54, the new dataset adds critical elements, improving signal detection through shared terminologies and standards. Key benefits include: 📌 Easier exchange of adverse event data for signal detection between jurisdictions. 📌 We have enhanced global collaboration for identifying and mitigating risks. 📌 Strengthened post-market surveillance efforts for medical devices and IVDs. As the healthcare landscape evolves, initiatives like this foster a safer, more transparent environment for regulators and industry. A step forward in making adverse event management systems more efficient, this harmonization ensures that patient safety remains at the forefront. #MedicalDevices #RegulatoryAffairs #PatientSafety #IMDRF #AdverseEventReporting #GlobalHealth
ICYMI: Manual 📝systems lead to inefficiencies and errors in med 💊 management that strain pharmacy workflows and directly impact resident wellness💖. Learn more about how @PointClickCare is addressing these challenges. #WTWPCC
ICYMI: Manual 📝systems lead to inefficiencies and errors in med 💊 management that strain pharmacy workflows and directly impact resident wellness💖. Learn more about how @PointClickCare is addressing these challenges. #WTWPCC
