Thrilled to have Ms Sophie Walsh as our guest speaker at the Asia-Pacific Network of Healthcare Service Regulators Webinar! Ms Walsh offered valuable insights on "The UK’s Innovative Devices Access Pathway Pilot" in addition to UK's innovative advancements in healthcare. Key takeaways: 🌟 Support: This pilot programme helps to provide structured and systematic support and advice for evidence generation to selected innovative medical devices projects. 🌟 Approval: Selection to this programme does not guarantee UK regulatory approval. However, manufacturers can apply for exceptional use authorization for market placement without regulatory approval, and such applications will be evaluated based on the general norms and criteria. 🌟 Evaluation: The IDAP pilot is currently being evaluated from both a systems and industry perspective. This evaluation aims to identify the strengths and areas for improvement in the future. 🤔 Missed it? Watch it here: https://lnkd.in/gempzcUs
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Did you know? 70% of healthcare professionals believe hybrid events are essential, yet they miss the networking of in-person congresses* Download the whitepaper now: ‘The future of medical congress, and how to meet the needs of healthcare professionals’: https://lnkd.in/eKiytVvF #PharmaNetworking #DigitalTransformation #HybridCongress * EPG Health “The Gaps Between HCP Demand and Pharma Supply of Medical Information” 2021
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Headed to Phoenix at the end of this week for the AAMI Conference. Look forward to being on the Regulate or Not to Regulate Medical Device Servicing panel with my two learned colleagues, Larry Hertzler and the esteemed and world-famous Dr. Binseng Wang. Should be a lively affair, and hope to see you there. 😁 To Regulate or Not to Regulate Medical Device Servicing? Regulatory Track Binseng Wang, ScD, CCE, Sodexo Clinical Technology Management; Larry Hertzler, MBA, BSEE, The InterMed Group; G. Wayne Moore, BSc, MBA, FASE, FAIUM, Acertara Acoustic Laboratories Some manufacturers and others have advocated for the FDA to regulate medical device servicing alleging patient safety and lack of regulations among other concerns, Servicers have contested that there is no data to support the claim of safety concerns and, since healthcare providers transfer many of their regulatory obligations to their servicers, there is no need for additional regulations. This and other points will be discussed by a panel of representatives from both sides of the issue to allow the audience to hear different points of view and decide for themselves
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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.
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📃 Study supporting the monitoring of the availability of medical devices on the #EU market (MD Availability). ◾ Exciting developments are underway as the European Commission's Directorate-General for Health and Food Safety, in partnership with European Health and Digital Executive Agency (HaDEA), launches a critical "Study supporting the monitoring of availability of medical devices on the EU market". ◾ Led by Gesundheit Österreich GmbH/GÖG, Areté, and Civic Consulting, this 36-month study aims to enhance medical device regulation. ◾ Ensuring the safety and availability of medical devices is crucial for public health. This initiative strengthens regulatory oversight and transparency. 🔗 Link : https://lnkd.in/eiJvCeNH 👇 Share your thoughts! Comment below to engage in discussions on this vital initiative... #EUHealthcare #MedicalDeviceStudy #PublicHealth #HealthcareInnovation #RegulatoryCompliance #EUMD #MDR #Medicaldevice #IVDR #Europe #ECREP #MDSS Windisch F, Zimmermann N, Habimana K, Knoll V, Fischer S, Vogler S (2023). One-pager (long version) on “Study supporting the monitoring of the availability of medical devices on the EU market (MD Availability)”. Gesundheit Österreich GmbH: Vienna. Available at: https://lnkd.in/dW-x8pC7
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𝗘𝘅𝗽𝗹𝗼𝗿𝗲 𝗖𝘂𝘁𝘁𝗶𝗻𝗴-𝗘𝗱𝗴𝗲 𝗜𝗻𝘀𝗶𝗴𝗵𝘁𝘀 𝗮𝘁 𝘁𝗵𝗲 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗣𝗿𝗼𝗱𝘂𝗰𝘁 𝗟𝗶𝗳𝗲 𝗖𝘆𝗰𝗹𝗲 𝗖𝗼𝗻𝗳𝗲𝗿𝗲𝗻𝗰𝗲 𝗶𝗻 𝗦𝘁𝗼𝗰𝗸𝗵𝗼𝗹𝗺 Don't miss the upcoming GBA Key2Compliance conference on the product life cycle of medical devices on October 8th and 9th in Stockholm, Sweden! Take part in an international event dealing with the complexity of regulations and standards for medical devices. The speakers are industry leaders who will provide you with the knowledge and tools you need to simplify complex processes. 🌟Why attend? This is a must-attend conference for professionals involved in product safety, quality, regulatory affairs, design and development, clinical/performance evaluations, post-market clinical follow-up activities, process development, or quality assurance. With insights from industry experts, legal perspectives, patient experiences and notified bodies, the program covers key activities in both the pre- and post-market phases. 🎤Featured Speakers: - Sharmila Gardner, Intertek Medical Notified Body - Pontus Gedda, RISE Research Institutes of Sweden - Anna Kuptel, TÜV SÜD - Richard Holborow, BSI - Judith de Wilde, Axon Lawyers - Erik Hansson, Senior Expert in Global Harmonisation of Medical Device Regulations - Cyrille Michaud, MD101 Consulting - Henrik Eriksson, Swedish Kidney Associate - Sandra Larsson, Technia - Dr. Madlon Timme & Dr. Kristina Then, GBA Medical Device Services - Azadeh Hajipour, GBA Key2Compliance 🔔 Seats are limited! Secure your spot and stay ahead in medical device innovation. You can find the registration link in the comments. We look forward to welcoming you in Stockholm! #GBAGroup #Key2Compliance #medicaldevices
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Welcome news from Medicines and Healthcare products Regulatory Agency (MHRA) on recognition of international #MedicalDevice #Regulatory approvals. Harmonisation is the way!
📢 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
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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
📢 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
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NAMSA’s most recent MedTech Matters Episode highlights Dr. Ken Ouriel, Chief Medical Officer at NAMSA, discussing the crucial strategies for selecting the proper investigational sites for clinical pivotal studies. Dr. Ouriel shares helpful insights to overcome common pitfalls in the clinical trial site selection process as well considerations for partnering with MedTech focused CRO’s to help navigate this potentially time consuming aspect to bringing lifesaving technologies to market. Watch now and elevate your site selection strategy: https://lnkd.in/e6SdTWK3 #MedTechMatters #ClinicalTrials #MedicalDevices #NAMSAKnows #PivotalStudies
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Ready to redefine feasibility and elevate healthcare? Unlock the secrets to efficient site selection, learn from industry experts, and revolutionize your clinical trials. Download the white paper: https://lnkd.in/gYEz2EAN #ResearchRevolution #ClinicalTrials #SiteFeasibility #FutureOfHealthcare 🌐🔬
Whitepaper: Redefining Feasibility - Research Revolution
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Clinical Evaluation Expert | I help you create your clinical strategy and accelerate your Clinical Evaluation process for your medical device. Contact Me 👇
🚨 Breaking Down the New Clinical Evidence Guidelines for Medical Devices from the Australian TGA Just got my hands on the latest Australian guidelines for medical devices, and there are some key points you need to know! 📚 🔍 Key Takeaways: 1) Updated Clinical Evidence Requirements: The guidelines have introduced significant changes in how we need to approach clinical evidence for device compliance. 2) Diverse Data Sources: Emphasizing a mix of clinical studies, literature reviews, and post-market data is now more important than ever for device approval. 3) Clinical Evaluation Report (CER): This document is very important a detailed analysis and expert opinions are crucial here. 🌍 Global Alignment, Local Impact: Australian standards are syncing up with international norms, yet they maintain unique Australian requirements. 💡 Let's Discuss! Thoughts, experiences, or questions about these changes? Drop them in the comments or DM me. 🔔 Stay Updated: Follow for more insights and updates in the world of medical devices and clinical evaluation!
