Snehlata Sharma’s Post

#RegUpdatesWithRegDesk ANMAT and ANVISA have agreed on " Mutual Recognition of Free Sale Certificates and Certificates for Foreign Countries for Medical Devices Risk Classes I and II and Medical Devices for In Vitro Diagnostics of Risk Classes A and B" recognising each other's certificates for certain medical devices. This decision aims to boost confidence in their decision and acknowledge efforts to promote public health safety and improve the regulatory processes. Link: 👉 https://lnkd.in/gkAZexFT Follow: 👉 RegDesk and get daily regulatory alerts sent straight to your inbox. Get Started: 👉 https://lnkd.in/d8yWnPkj #regdesk #holisticrims #rims #software #entrepreneurship #medtech #lifescience #healthcare #health #diagnostics #meddevice #regulations #pharmaceutical #pharmaceuticalindustry #ai #technology #future #innovation #medicaldevices #regulation #argentina #brazil

I'm thrilled to highlight the groundbreaking advancements in non-invasive drug testing technology by Intelligent Bio Solutions Inc. (INBS). Their innovative approach leverages sweat technology to provide rapid and intelligent testing solutions. Sweat technology is revolutionizing the field by offering a non-invasive, user-friendly method for drug screening. Unlike traditional methods that rely on blood, saliva, or urine, sweat collection is quick, painless, and less intrusive, making it an ideal solution for various settings, including workplaces, clinics, and law enforcement. INBS is at the forefront of this innovation with their Intelligent Fingerprinting Drug Screening System, which includes a drug screening cartridge, a DSR-Plus fluorescence reader, and a collection kit for laboratory analysis. This cutting-edge system not only simplifies the testing process but also enhances accuracy and reliability. As INBS navigates the FDA 510(k) regulatory pathway, the recent commencement of their pharmacokinetic (PK) study marks a significant milestone. This study will deepen our understanding of opiate metabolism, distribution, and excretion in human sweat, paving the way for broader applications of this technology. Exciting times ahead as we witness the transformation of drug testing through sweat technology, driven by INBS's relentless pursuit of innovation and excellence. #MedicalTechnology #Innovation #NonInvasiveTesting #SweatTechnology #DrugScreening #HealthcareInnovation #INBS

South Korea News! (Unique Device Identification (UDI)) The Ministry of Food and Drug Safety (Medical Device Management Division) of South Korea has today released the English translated version of the "Regulations on Unique Device Identification Management". The Regulation provides details on the information that medical device manufacturers and importers are required to register in the unique device identification (UDI) system. The original notice was first published in 2019. For more MedTech, Pharma, BioTech News, Regulatory Intelligence, PMS automation, Clinical Literature automation, Research, Intelligence and much more, log onto www.medboard.com or contact us.   #intelligence #notifiedbody #notifiedbodies #audit #medboard #medicaldevices #medtech #eumdr #hospital #medicaldevice #medicaldevices #surveillance #automation #regulatoryintelligence #clinicalinvestigations #southkorea

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The life cycle of a running a clinical trial is constantly evolving. The goal is to end on time and within budget. What is your risk mitigation plan?

▶️ User unmet needs: Towards mitigating the incidence of incorrect differentiation of insulin long acting & rapid acting medicines in pen devices at the domestic setting Join Dr. William Denny, Sandoz Device Development Centre and the industry leaders in exploring the forefront of industry trends, connecting with professionals, and gaining insights that drive progress, sign up for the upcoming #VLDDCP 🔸6th Drug-Device Combination Products🔸 📆October 15-16, 2024 📍 Berlin, Germany 🔗Register 👇 https://buff.ly/4cH86Xd The summit aims to address the critical importance of ensuring harmony between drug products and their delivery mechanisms towards the successful advancement of sustainable and connected combined drug-device products #combinationproducts #design #engineering #drugdelivery #future #digital #connecteddevices #medicaldevices #compatibility #suspensions #sustainability #digitalhealth #autoinjector #injectors #medtech #contractmanufacturing #drugdevelopment #DDSs #innovation #conference #summit #ssr #humanfactors #pharmaceuticalmanufacturing #regulatory #externalinnovation #formulation #injectabledrugs #injectables #injectiondevices #digital #materialscienc

Explore how Retinae's advanced quality control systems are enhancing operations in the biomedical sector with our project for Fresenius Kabi Italia. We needed to integrate our system with existing vision systems on the production line, as the original supplier couldn’t provide the specialized filter inspection required. We also had to ensure our V-BASE system was calibrated for high-precision biomedical applications, despite its adaptability, given the complexity and importance of the task. Dive into the details in our case study 👇 #BiomedicalEngineering #QualityControl #Innovation #Retinae"

Safety substantiation is a crucial part of a robust product development and testing protocol. Safety substantiation testing uses test data and analysis of the chemical composition of a cosmetic or drug product to determine a product's safety under customary use and foreseeable misuse. There are several tests that can be completed to determine the safety of a product including both preclinical and in-use clinical testing with subjects. Whether you are launching a new cosmetic or drug product or looking to improve your safety substantiation to comply with MoCRA, CPT℠ can help! Contact us today to learn more and discuss a safety substantiation protocol with our experts. https://bit.ly/3V0C5SG #ProductSafetyTesting #MoCRA #SafetySubstantiation

Clinical trials require strict oversight to make sure both safety and success are achieved. Proper monitoring verifies protocols are followed, and the data collected is accurate because issues, when left unchecked, can delay results and regulatory approval. During trials, qualified monitors visit sites, observe procedures, and audit documents. They also identify and correct non-compliance quickly before small problems become large setbacks. The result? With effective clinical monitoring, sponsors can have confidence any deviations or errors won't compromise trial integrity or participant well-being. To learn how our experienced monitors can provide oversight for your next study, visit https://lnkd.in/dQP4UVrN #pharma #research #biotech #medical #monitoring #qualityassurance #quality #drug

#Partner #MedicalDeviceSummit2024 We are delighted to welcome on board Instron as Networking Partner at the upcoming 8th Annual Medical Device Regulatory & Quality Summit 2024 taking place on 22-23 August in New Delhi. Registration link for the conference - https://bit.ly/3SuumMk Instron® brings a wealth of knowledge to the biomedical industry, serving as a strategic partner to companies of all sizes. Their equipment and services are primed to help you investigate new technologies and ensure product quality, maintaining the highest levels of data integrity and security. The technological, regulatory, and manufacturing challenges facing customers have driven us to develop products and services that include specialized fixturing, compliant software, and automation capabilities. Their most valuable asset is the extensive customer network, which represents a wide range of medical device and pharmaceutical manufacturers, CDMOs, universities, test houses, and startups. Head over to www.instron.com for more details. #MedDeviceSummit2024 #RegulatoryCompliance #QualityAssurance #MedicalDeviceRegulations #DeviceQuality #HealthcareInnovation #CDSCORegulations #MedicalDeviceStandards #RegulatoryAffairs #QualityManagement #MedicalDeviceIndustry #RegulatoryUpdates #MedTech2024 #ComplianceMatters #ClinicalEvalution #MDRcertification #ProductRegulations #MedicalDeviceClassification #PatientSafety #MedicalDeviceWaste #biomedicalindustry #compliantsoftware #automation