📹 Discover the Top 5 Videos to Master Post Market Surveillance in 2024 for Medical Devices and IVDs! Stay informed and elevate your knowledge with our latest blog post! 🚀 https://lnkd.in/dYtkmHMB Marcus Emne Martin King Monir El Azzouzi Bijan Elahi Naveen Agarwal, Ph.D. InnoScot Health Steve Curran #MedicalDevices #IVD #PostMarketSurveillance #Regulations #Top5Videos
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Medical devices include a wide range of tools designed to prevent, diagnose, or treat #health conditions. In the field of home-based rehabilitation, solutions like ARC, our medical device for #telerehabilitation, are transforming patient support by enabling remote recovery and functional maintenance. Each medical device has a specific “intended purpose” defined by the manufacturer and regulated under the European Medical Device Regulation (#MDR 2017/745).This regulation ensures devices like ARC are safe, effective, and used in compliance with current regulations. Would you like to know more about how to choose the right medical devices? » https://lnkd.in/dicF9r4c
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This article explores some of the most dangerous #medicaldevices ever to hit the market. These devices have caused serious harm to patients - and the industry's reputation. Discover the details here: https://utm.io/ugKyl
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New Blog Alert! 🚨 Guide to Australian Medical Device Standards and Regulations 🩺 Medicine involves the use of a vast array of innovative devices. While the use of such devices could involve a level of risk to patients, these risks can be mitigated through medical device regulation and standardisation. Learn more and read the blog 👉 https://lnkd.in/g6MDuszt #MedicalDevice #Standards
Medical Device Standards
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This Editorial discusses the limitations of current postmarket surveillance systems for medical devices, highlighting the case of inferior vena cava filters (IVCFs). https://ja.ma/3YS9ySp
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It is not just with artificial intelligence-enabled medical devices that the FDA 510(k) process raises issues. Legacy devices, like inferior vena cava filters which have been used for prevention of pulmonary embolism (PE) since the 1960s and have been approved without requiring demonstration of clinical effectiveness (eg, reduced risk for subsequent PE or PE-related death), also have important gaps in post-marketing surveillance (PMS) about the persistence of risks and benefits. There is still a lack of ability to conduct large-scale, routine medical device safety evaluations repeatedly over the product life cycle, because of gaps in health systems electronic health records (eHR), for example. For the eHR digital transition, standardization is key. https://lnkd.in/gKSdcRUj
This Editorial discusses the limitations of current postmarket surveillance systems for medical devices, highlighting the case of inferior vena cava filters (IVCFs). https://ja.ma/3YS9ySp
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Missed our latest webinar with Nick Atkins on contact lens care innovation? 🌟 Watch the recording now to discover Povidone-iodine, a new whole level of lens care disinfection options and learn about the impact of Medical Device Regulations! 👉 Available here: https://lnkd.in/ez4yEfNX #RPG #RPGlens #lenscare #lensdesinfection #Scleral #Sclerallens #Scleralcare #contactlenses #contactlens #webinar #freewebinar #watchwebinar
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Not only do cyberattacks cost dollars, they cost lives. Cyberattacks can shut down medical devices and block access to important medical records. Contact us to safeguard your data AND patient lives. https://lnkd.in/enFkt-eq #healthcareIT
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Ever wondered why unanswered medical device alarms aren't labelled as a 'Never Event'? Read our in-depth analysis to understand the complexities surrounding this crucial topic. 🚑🔔🏥 🔗 https://lnkd.in/eKEdKfxV #HealthcareInsights #PatientSafety #BEAMS #NHS #Healthtech #DigitalHealth #HealthCareInnovation #MedDevice #MedTech #WardEfficiency #StaffEfficiency #PatientExperience #TechInHealthcare #PatientMonitoring #WardManagement
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💓 SmartCardia gets FDA nod for telemetry feature on its 7L ECG Patch The health technology company recently received FDA approval for its 7-lead (7L) ECG monitoring patch, for Extended Holter, Event and Holter monitoring. The 7L patch is a cable-free, waterproof continuous monitoring device that can be used for up to 14 days to monitor 7-Lead ECG and vitals. The expanded FDA approval allows the 7L patch to be used for remote live monitoring of patients’ ECG and immediately notify clinicians of important arrhythmias. Read more online: https://lnkd.in/ePPv3rng 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #medicaldevices #medicalmanufacturing
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Such a cool story about how Holy Name Medical Center is helping both patients and clinicians through an innovative approach to IV access and technologies like the PIVO™ Needle-free Blood Collection Device. There are tons of great takeaways here for hospitals trying to advance vascular management for their patients. Read the article! #BDemployee
New case study from Holy Name Medical Center in Nurse Leaders
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Founder & Prin. Consultant, JMT Compliance Consulting | Medical Device QA/RA Executive | Fractional CQRO | Digital Health | SaMD(AI) | Mentor | Instructor | Connector | Advisor |
8moAll amazing content! Naveen Agarwal, Ph.D. well done!!