Evnia’s Post

🔍 NAMSA teams up with DeviceMed to spotlight the revolutionary ANSI/AAMI ST98 guidelines for validating cleaning instructions of reusable medical devices, ensuring safety and efficacy in healthcare. 📝 "A Standard for Validating Reusable MD Cleaning Instructions" explores a criticality-based standard poised to be an international benchmark. 🧪 This article highlights the rigorous validation of reprocessing instructions for patient safety and compliance, covering risk analysis to marker analysis. 🌐 Read the full article for a comprehensive understanding of the new standard's expectations and its significance in the medical device industry. 🔗 https://lnkd.in/gJqX86XX #NAMSAKnows #DeviceMed #MedicalDevices #HealthcareStandards #ANSIAAMI

🔍 NAMSA teams up with DeviceMed to spotlight the revolutionary ANSI/AAMI ST98 guidelines for validating cleaning instructions of reusable medical devices, ensuring safety and efficacy in healthcare. 📝 "A Standard for Validating Reusable MD Cleaning Instructions" explores a criticality-based standard poised to be an international benchmark. 🧪 This article highlights the rigorous validation of reprocessing instructions for patient safety and compliance, covering risk analysis to marker analysis. 🌐 Read the full article for a comprehensive understanding of the new standard's expectations and its significance in the medical device industry. 🔗 https://lnkd.in/gJqX86XX #NAMSAKnows #DeviceMed #MedicalDevices #HealthcareStandards #ANSIAAMI

US FDA News!! (Generative AI-Enabled Devices) The FDA Digital Health Advisory Committee (DHAC) has published an executive summary on "Total Product Lifecycle Considerations for Generative AI-Enabled Devices" On November 20-21, 2024, the Digital Health Advisory Committee will discuss total product lifecycle considerations for generative AI-enabled medical devices. Link to event details: https://lnkd.in/e_egSnnD #intelligence #notifiedbody #notifiedbodies #audit #ivd #medtech #euivdr #eumdr #medicaldevice #medicaldevices #surveillance #automation #regulatoryintelligence #clinicalinvestigations #udi #fda #genai #tplc

I was often mentioning that #TUVSUD is providing a new level of service for medical Device market access according to #MDR. Here are more details

Predictability! When to expect an report and a decision! Listen to Andreas and Martin about what our new notified body in Denmark is offering.

Top Story of 2024: Our Top Stories series continues with a major regulatory achievement in Canada! The KA Imaging’s Reveal Mobi Pro™ has received a Canadian Medical Device Licence from Health Canada in May 2024! This premium dual-energy mobile system, launched in collaboration with Del Medical, Inc., brings advanced imaging capabilities to healthcare settings across Canada. Read the full story on our website! Read more: https://lnkd.in/ecNqc4ei

Health-ISAC Members and staff discuss the criticality of secure medical devices and how device manufacturers and healthcare delivery organizations collaborate for patient safety in Health-ISAC's Medical Device Security Council (MDSC.) https://lnkd.in/eaTQjah5 #medicaldevices #lifesciences #SBOM

Understanding the Vital Role of Post-Market Surveillance for Medical Devices in the USA In the ever-evolving world of medical technology, ensuring the safety and effectiveness of medical devices extends far beyond the premarket phase. While rigorous testing and clinical trials are crucial, they often can't capture every potential risk or benefit. That’s where post-market surveillance steps in! This ongoing process plays a critical role in identifying new risks, uncovering long-term effects, and ensuring that devices meet safety standards throughout their lifecycle. Explore more about the FDA’s approach to post-market surveillance and why it’s crucial for medical device safety in our latest blog post! Read More : https://lnkd.in/gHWcVqYc #MedTech #MedicalDevices #FDA #PostMarketSurveillance #HealthcareInnovation #PatientSafety #RegulatoryAffairs

Did you know❓ The Council has just adopted new measures aimed at preventing shortages and facilitating a smoother transition towards greater transparency and accessibility of information in the medical devices industry. These updated rules will play a crucial role in ensuring the availability of critical medical devices while maintaining safety standards. 💊💡 Key highlights of the regulation adopted, include: ✅ Further extension of the transition period for certain in-vitro diagnostic medical devices (IVDs).  ✅ Gradual roll-out of EUDAMED, the new electronic database, to enhance transparency and accessibility of information.  ✅ Requirement for manufacturers to flag potential shortages of critical medical devices and IVDs, ensuring timely intervention. ➡️https://lnkd.in/dMuU_6Su #medicaldevices #medicaldeviceregulation #IVDR #MDR #EUDAMED #Healthcare #PatientSafety #medxteam 

📢FDA releases the 2024 safety and innovation reports for medical devices. ✅It is good to see a strong focus on protecting patients while also accelerating innovation. 🚀Action plan for safety in 2024: 1️⃣ Advance improved device quality 2️⃣ Strengthen active surveillance 3️⃣ Enhance medical device recall program ❗Highly publicized quality issues at big companies like Boeing and Philips are creating good public awareness. ✅This is good news for patients and doctors. ❓How are you planning to boost quality and safety of your medical device? Share in comments below 👇 ======================================= Like this post? Follow me Naveen Agarwal, Ph.D. and hit the 🔔 so you don't miss my posts.