OSMR - The Romanian Medicines Serialisation Organisation’s Post

Exciting news! Our ComASUR® Delivery System for our DurAVR® Transcatheter Heart Valve earned an Honorable Mention in the packaging category of Fast Company’s prestigious and highly competitive Innovation by Design Awards! This award is more than just recognition – it validates our commitment to forging new frontiers in cardiac care. Our unique packaging solution, developed in collaboration with IDEAZ, includes added functionality designed to enhance TAVR setup and streamline processes. The thermoform tray includes features such as a kickstand for easier insertion to the crimper and reservoirs for liquids used in the procedure. This award is a testament to our dedication to daring to do things differently – because that’s what leads to groundbreaking scientific advancements. See how we’re making a difference: https://lnkd.in/gCrayzkM #FCDesignAwards #innovation #packaging #TAVR #TAVI DurAVR® INVESTIGATIONAL USE ONLY. NOT AVAILABLE FOR COMMERCIAL SALE. ComASUR® Delivery System INVESTIGATIONAL USE ONLY. NOT AVAILABLE FOR COMMERCIAL SALE. EU: Exclusively for clinical investigations. US: CAUTION – Investigational Device. Limited by Federal (or United States) law to investigational use.

Pilots use flight simulators to hone their skills before taking off—why should doctors be any different? United Biologics' vascular models offer physicians hands-on practice for procedures with stents, catheters, and medical devices. Realistic, controlled training environments build confidence and precision long before the real-life stakes begin.

NEED TO USE IMMAD. IMMAD-VR is an objective test of peripheral retinal functions using VR goggles displaying small striped squares that test for marijuana impairment roadside. Marijuana impairs visual functions critical for safe driving. If a driver cannot see accurately cannot drive safely. https://lnkd.in/emGemtrf

Oral fluid identifies what drug. but still require an objective test of functions critical for safe driving. IMMAD-VR is an objective test of peripheral retinal functions using VR goggles displaying small striped squares that test for marijuana impairment roadside. https://lnkd.in/eHd6mQnf

The #MDCG 2024-11 guidance, released in October 2024, focuses on the qualification of #in vitro diagnostic medical devices (IVDs) under the #EU IVDR 2017/746 regulation. This document aims to help manufacturers to determine whether a product qualifies as an #IVD device or accessory based on its intended purpose.   Here are some examples of products for #general laboratory use and #IVDs (non-exhaustive) mentioned in MDCG 2024-11. For more information, please click on the below link! https://lnkd.in/gy4mYzCg #IVDR #IVD #APR #CPR #SVR #PER #invitro #diagnostic #medicaldevice #EU2017/746 #MDCG #clinical #performance #safety #CEmarked Kuldeep Tyagi Ankur Aggarwal Rohit Gupta Dan Wood Kshitij Kumar Satyam Sahu Vaibhav Tyagi

There is a desperate need of objective tests of functions critical for safe driving that are free of racial bias. IMMAD-VR is such a test. It is not impacted by pigment as near infrared forehead brainwave tests are. These are inaccurate in 35% of Blacks. IMMAD-VR is a simple VR goggle displaying small striped squares that test for marijuana impairment roadside. IMMAD-VR measures peripheral retinal response. IMMAD is owned by a Massachusetts Cannabis Control Commission certified Marijuana Social Equity business owner... and equity and social justice on our roafs, is a priority. #IMMADtestsMJdui https://lnkd.in/eWTkasR6

Under the #InVitro Diagnostic Regulation (IVDR), a #ClinicalPerformance Report (CPR) specifically refers to the evaluation and documentation of how well an in vitro diagnostic (IVD) device performs in a clinical setting.   The #IVDR (Regulation (EU) 2017/746) sets stringent requirements for IVDs in the #European Union, focusing on #safety, #performance, and #clinical evidence.   Clinical Performance Report for #IVDs involves comprehensive clinical evidence demonstrating that the device reliably performs its intended purpose, while meeting #safety and #efficacy standards throughout its lifecycle. #IVDR #IVD #APR #CPR #SVR #PER #invitro #diagnostic #medicaldevice #EU2017/746 #clinical #performance #safety #CE #Saraca Kuldeep Tyagi Ankur Aggarwal Rohit Gupta Dan Wood Vaibhav Tyagi Kshitij Kumar Satyam Sahu

This short video 📹 from a webinar talks about our AI-assisted cap analog discovery platform and caps under development. Click play to watch. Like this post or drop a comment below if you enjoyed the video! #mRNA #capanalogs #mrnavaccines #RNA

As a result of the new #invitro device regulation requirements (#IDVR), many EU #medicaldevices that were previously self-certified as class A may need to be reclassified. Make sure you get your device's classification right by following this guidance: https://bit.ly/3YuLYvj

☑️ FDA grants 510(k) clearance for new functionality of Varian’s Ethos system, streamlining daily treatment adaptation for various body areas. ☑️ Health Canada grants a Class III license to Qure.ai’s medical imaging AI solutions, enhancing diagnostic precision and efficiency. ☑️ Strata Skin Sciences’s XTRAC Momentum 1.0 laser receives approval in Japan, allowing targeted UVB light therapy for specific skin areas. ☑️ Magenta Medical Ltd. secures $105 million to trial the world’s smallest heart pump, preparing for pivotal trials in the US for FDA approval in mechanical circulatory support indications. ☑️ Spryte Medical’s nOCT technology secures breakthrough device designation, offering high-resolution imaging of the brain's vascular structures. #InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr