HATEM RABEH, MD, MSc ing’s Post

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📢 We've announced a framework for international recognition of medical devices📢 💡 This initiative signals an important step towards a new regulatory framework for medical devices in Great Britain which protects public health, ensures access to MedTech innovations, and maintains an attractive market for industry. Our Chief Quality and Access Officer, Dr Laura Squire, said: "Today’s announcement is an important step forward towards a robust MedTech regulatory framework that prioritises patient safety, gives patients access to the medical devices they need and ensures the UK remains an attractive market for medical technology innovators. "We will continue to work on how our intended policy on international recognition of medical devices will operate in practice. By sharing the draft policy now, we aim to give greater clarity about the MHRA’s future direction of making regulatory approvals simpler, where it is safe to do so. At the same time, we remain fully committed to the UKCA marking for medical devices. "We continue to expand capacity in UK Approved Bodies and to work to ensure UKCA marking supports safe and earlier access to the most innovative and transformative medical products." To read the full announcement, visit ➡️ https://bit.ly/3WPrUCL

So… The MHRA is continuously moving the glass to regulatory reform! Still in draft but a very welcome news!!! 🎊 🙌🏽 Benefits: - faster market access to serve patient needs - reduced regulatory burden Exciting months ahead! #mhra #medicaldevices

Welcome news from Medicines and Healthcare products Regulatory Agency (MHRA) on recognition of international #MedicalDevice #Regulatory approvals. Harmonisation is the way!

After analyzing 1,000+ medical entity launches we have identified some key patterns. Stay ahead of the curve and find out how Medical Affairs can drive your launch success in 45 minutes with this on-demand webinar from speakers Catarina Santos PhD, MBA and David Kelaher. https://bit.ly/3w1x047 #MedicalAffairs #LaunchExcellence

🤔 How do you define the clinical benefit for a medical device? Defining the clinical benefit of a medical device can be complex. In many cases, there is no clear association of the clinical benefit to the intended purpose of a device. As highlighted again in the latest update of MDCG 2021-6, the following definitions can guide you: 1️⃣ Performance: The ability of a medical device to achieve its intended purpose as stated by the manufacture. 2️⃣ Clinical performance: The ability of a medical device to achieve its intended purpose, thereby leading to a clinical benefit. 3️⃣ Clinical benefit: Positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s). 💡 Impact on clinical evidence: How we define the clinical benefit directly influences the level of evidence required for a medical device. Understanding the nuances of direct and indirect clinical benefits is paramount. A clear definition sets the stage for robust evidence collection. 🚀 Therefore: Align with intended purpose: Ensure your definition aligns seamlessly with the device's intended purpose and performance criteria. Use a patient-centric approach: Whenever possible, define outcomes that matter to patients. Generate evidence: Align your strategy for clinical data collection with the clinical benefit – whether direct or indirect. #mdr #medicaldevices #clinicalevaluation #clinicalbenefit

Online Seminar/Training – Clinical Evaluation and Clinical Evidence for Medical Devices To provide clinical evidence in the clinical evaluation is the responsibility of the manufacturer. Not an easy task for a lot of medical devices. Comprehensive & detailed guidelines are still not available - thus a challenging obligation. This seminar will help you to understand the fundamentals of identifying and generating clinical evidence for your medical devices - and the interrelation with the clinical evaluation.    Covered topics: ✅Regulatory Framework for Clinical Evaluation ✅Clinical Data and Clinical Evidence ✅Clinical Evaluations and Clinical Investigations  ✅Clinical Evaluation throughout Medical Device Lifecycle ✅Real World Evidence ✅How Clinical Evidence links to Risk Management, Biocompatibility, PMS   The online seminar is presented by our Senior Consultant @Dr. Susanne Gerbl-Rieger, distinguished by her long-time experience working with one of the biggest notified bodies and in clinical research and regulatory consulting.   Learn more and register now: https://lnkd.in/ddn6QXiz   #training #online #ClinicalEvaluation #regulatoryaffairs #clinicalaffairs #medicaldevices #clinicalevidence #clinicaldata #MDR #registration #clinicalinvestigation #realworldevidence

The MHRA proposed a new framework for international recognition of medical devices, ensuring safe and timely access to innovative MedTech in Great Britain. This initiative will recognise approvals from trusted countries like the EU, USA, Canada, and Australia. Stay tuned for more updates! #InternationalAssociates #Healthcare #MedicalDevices #Technology #MedTech #QualityAssurance #SafetyFirst #Audit #Compliance

The journey of developing a clinical study is a dynamic and continuous process. By meticulously planning and embracing the latest technological solutions, you empower your team to navigate the complexities of clinical research successfully. The robust clinical evidence you generate becomes the cornerstone for regulatory submissions and/or market adoption for your target audiences. Is your team prepared to develop a successful study? Share your thoughts, experiences, or questions in the comments below! What other elements do you consider when developing and planning a medical device clinical trial? Let’s learn from each other.  #ClinicalAffairs #MedicalDevices #ClinicalResearch #StrategyPlanning #ClinicalTrials #ClinicalStudyManagement https://lnkd.in/gwcm37mk

Argentina's rise as a medtech clinical trial destination is driven by its adherence to quality standards, innovative medical device contributions, and strong healthcare infrastructure. The country's regulatory framework and growing market demand position it as a favorable location for global research. With a focus on efficiency and patient safety, Argentina offers a promising landscape for advancing medical science through clinical trials.