Irish Medtech

𝗛𝗼𝘄 𝗰𝗮𝗻 𝗤𝗔𝗥𝗔 𝘁𝗲𝗮𝗺𝘀 𝗮𝗰𝘁 𝗮𝘀 𝗼𝗿𝗴𝗮𝗻𝗶𝘀𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗲𝗻𝗮𝗯𝗹𝗲𝗿𝘀 𝗮𝗻𝗱 𝗰𝘂𝘀𝘁𝗼𝗱𝗶𝗮𝗻𝘀 𝗼𝗳 𝗾𝘂𝗮𝗹𝗶𝘁𝘆 𝗰𝘂𝗹𝘁𝘂𝗿𝗲 𝗮𝗰𝗿𝗼𝘀𝘀 𝘁𝗵𝗲 𝗲𝗻𝘁𝗶𝗿𝗲 𝗼𝗿𝗴𝗮𝗻𝗶𝘀𝗮𝘁𝗶𝗼𝗻? As regulatory requirements grow more complex and organisations embrace digital transformation, quality and regulatory affairs professionals play a critical role in embedding quality beyond compliance functions and throughout the organisation. From product development and manufacturing to supply chain management and post-market activities, a strong culture of quality is becoming a key driver of regulatory, operational and business success. Join us at Global Access 2026 for 𝗖𝘂𝗹𝘁𝘂𝗿𝗲 𝗼𝗳 𝗤𝘂𝗮𝗹𝗶𝘁𝘆: 𝗗𝗿𝗶𝘃𝗶𝗻𝗴 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗮𝘁 𝗦𝗰𝗮𝗹𝗲 𝗮𝘁 𝗘𝘃𝗲𝗿𝘆 𝗦𝘁𝗮𝗴𝗲 𝗶𝗻 𝘁𝗵𝗲 𝗟𝗶𝗳𝗲𝗰𝘆𝗰𝗹𝗲, moderated by Robbie Walsh, Vice President of Quality Assurance and Regulatory Affairs at AOTI. This session will explore how new technologies and evolving regulatory and legal requirements are reshaping quality and regulatory operations, from eQMS and digital technical documentation to AI, data governance and supply chain resilience. As quality becomes an increasingly important driver of business performance, attendees will gain practical insights into how QARA teams can help shape strategy, strengthen resilience and deliver quality outcomes at scale across the organisation. Book your ticket now and discover how leading organisations are building quality, resilience and regulatory excellence at scale - https://lnkd.in/ecJsV_F #GlobalAccess2026 #IrishMedtech #QualityCulture #QualityAssurance #RegulatoryAffairs #DigitalTransformation #eQMS #MedicalDevices #Medtech #SupplyChainResilience

𝗔𝘀 𝘀𝘂𝘀𝘁𝗮𝗶𝗻𝗮𝗯𝗶𝗹𝗶𝘁𝘆 𝗺𝗼𝘃𝗲𝘀 𝗳𝗿𝗼𝗺 𝗮 𝗰𝗼𝗿𝗽𝗼𝗿𝗮𝘁𝗲 𝗮𝗺𝗯𝗶𝘁𝗶𝗼𝗻 𝘁𝗼 𝗮 𝗺𝗮𝗿𝗸𝗲𝘁 𝗮𝗰𝗰𝗲𝘀𝘀 𝗿𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁, 𝗵𝗼𝘄 𝗰𝗮𝗻 𝗺𝗲𝗱𝘁𝗲𝗰𝗵 𝗰𝗼𝗺𝗽𝗮𝗻𝗶𝗲𝘀 𝗿𝗲𝗺𝗮𝗶𝗻 𝗶𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝘃𝗲, 𝗰𝗼𝗺𝗽𝗲𝘁𝗶𝘁𝗶𝘃𝗲 𝗮𝗻𝗱 𝗰𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝘁? Environmental regulations are increasingly shaping business strategy, product development and market access across the medtech sector. Manufacturers are now expected to demonstrate not only safety, performance and clinical benefit, but also responsible management of materials, emissions, packaging, waste and supply chain impacts. Join us at Global Access 2026 for 𝗦𝘂𝘀𝘁𝗮𝗶𝗻𝗮𝗯𝗹𝗲 𝗠𝗲𝗱𝗧𝗲𝗰𝗵: 𝗘𝗻𝘃𝗶𝗿𝗼𝗻𝗺𝗲𝗻𝘁𝗮𝗹 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻𝘀 𝗮𝗻𝗱 𝘁𝗵𝗲 𝗘𝘃𝗼𝗹𝘃𝗶𝗻𝗴 𝗥𝗼𝗹𝗲 𝗼𝗳 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗔𝗳𝗳𝗮𝗶𝗿𝘀, moderated by Karen Hyland, Senior Director of Regulatory Affairs at Medtronic. Bringing together perspectives from sustainability, product development and European policy, this panel will explore how emerging environmental regulations are influencing product design, competitiveness and access to global markets. The discussion will examine how organisations can embed sustainability across the product lifecycle while balancing environmental goals with patient safety, operational resilience and commercial success. As healthcare systems, governments and procurement bodies place greater emphasis on sustainability, regulatory affairs professionals are becoming key strategic partners in helping organisations prepare for future requirements. Book your ticket today and gain practical insights into the sustainability trends and environmental regulations shaping the future of medtech - https://lnkd.in/ecJsV_F #GlobalAccess2026 #IrishMedtech #Sustainability #Medtech #RegulatoryAffairs #MarketAccess #MedicalDevices

𝗪𝗵𝗮𝘁 𝗱𝗼𝗲𝘀 𝗲𝗳𝗳𝗲𝗰𝘁𝗶𝘃𝗲 𝗲𝗻𝗴𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝘄𝗶𝘁𝗵 𝘁𝗵𝗲 FDA 𝗹𝗼𝗼𝗸 𝗹𝗶𝗸𝗲 𝗶𝗻 𝘁𝗼𝗱𝗮𝘆'𝘀 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗲𝗻𝘃𝗶𝗿𝗼𝗻𝗺𝗲𝗻𝘁? As regulatory requirements continue to evolve, successful market access increasingly depends on more than compliance alone. Manufacturers need a clear understanding of FDA priorities, emerging expectations and the value of meaningful regulator-industry engagement. Join us at Global Access 2026 for two FDA-focused sessions that will provide perspectives from both FDA and industry experts on the trends, opportunities and challenges shaping regulatory engagement in the United States. On day one, 𝗨𝗦 𝗠𝗮𝗿𝗸𝗲𝘁 𝗙𝗼𝗰𝘂𝘀 – 𝗘𝗻𝗵𝗮𝗻𝗰𝗶𝗻𝗴 𝗣𝗮𝗿𝘁𝗻𝗲𝗿𝘀𝗵𝗶𝗽𝘀 𝘄𝗶𝘁𝗵 𝘁𝗵𝗲 𝗙𝗗𝗔, moderated by Robbie Walsh, Vice President of Quality Assurance and Regulatory Affairs at AOTI, will explore current FDA initiatives, QMSR implementation, international harmonisation efforts and the growing role of digital technologies in the regulatory landscape. On day two, 𝗙𝗗𝗔 𝗮𝗻𝗱 𝗜𝗻𝗱𝘂𝘀𝘁𝗿𝘆 𝗶𝗻 𝗗𝗶𝗮𝗹𝗼𝗴𝘂𝗲: 𝗛𝗼𝗿𝗶𝘇𝗼𝗻𝘁𝗮𝗹 𝗟𝗲𝗮𝗿𝗻𝗶𝗻𝗴 𝗔𝗰𝗿𝗼𝘀𝘀 𝗩𝗲𝗿𝘁𝗶𝗰𝗮𝗹 𝗦𝘁𝗿𝘂𝗰𝘁𝘂𝗿𝗲𝘀, moderated by Sharon Fahy, Vice President of Regulatory Affairs at Medtronic, will examine how programmes such as the FDA Focal Point Program can strengthen communication, support organisational learning and enhance regulatory decision-making across industry and regulators. Industry perspectives on the evolving FDA landscape will be shared by Rosaleen (Roz) Burke, Chief Quality Officer and Senior Vice President Global Quality and Regulatory at Boston Scientific, and Jim Kleinedler, PhD, Director of Regulatory Strategy at Medtronic. Together, these sessions will provide practical insights into FDA priorities, regulatory intelligence, market access strategies and the evolving relationship between industry and regulators. Book your ticket now and gain valuable perspectives on the partnerships, policies and regulatory approaches shaping the future of FDA engagement - https://lnkd.in/ecJsV_F #GlobalAccess2026 #IrishMedtech #FDA #RegulatoryAffairs #Medtech #RegulatoryStrategy #MedicalDevices #RegulatoryIntelligence #QualityAssurance

𝗔𝘀 𝘁𝗵𝗲 𝗯𝗼𝘂𝗻𝗱𝗮𝗿𝗶𝗲𝘀 𝗯𝗲𝘁𝘄𝗲𝗲𝗻 𝗽𝗵𝗮𝗿𝗺𝗮𝗰𝗲𝘂𝘁𝗶𝗰𝗮𝗹𝘀 𝗮𝗻𝗱 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲𝘀 𝗰𝗼𝗻𝘁𝗶𝗻𝘂𝗲 𝘁𝗼 𝗯𝗹𝘂𝗿, 𝗰𝗮𝗻 𝗘𝘂𝗿𝗼𝗽𝗲'𝘀 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗳𝗿𝗮𝗺𝗲𝘄𝗼𝗿𝗸 𝗸𝗲𝗲𝗽 𝗽𝗮𝗰𝗲 𝘄𝗶𝘁𝗵 𝗶𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝗼𝗻?   Combination products are increasingly being recognised as a distinct category of healthcare innovation, requiring new approaches to regulation, collaboration and governance. As the regulatory landscape evolves, the challenge is creating a more predictable and innovation-friendly environment that supports patient access while maintaining high standards of safety and performance. Join us at Global Access 2026 for 𝗖𝗼𝗺𝗯𝗶𝗻𝗮𝘁𝗶𝗼𝗻 𝗣𝗿𝗼𝗱𝘂𝗰𝘁𝘀: 𝗨𝗻𝗹𝗼𝗰𝗸𝗶𝗻𝗴 𝗦𝗺𝗮𝗿𝘁𝗲𝗿 𝗣𝗮𝘁𝗵𝘄𝗮𝘆𝘀 𝗳𝗼𝗿 𝗜𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝗼𝗻, moderated by Claire O'Brien, Director of Regulatory Affairs at Boston Scientific. Bringing together perspectives from industry and Notified Bodies, this panel will explore lifecycle management, regulatory predictability, post-approval changes and the role of collaboration in supporting innovation and competitiveness. Book your ticket now and join the discussion on creating smarter, more predictable pathways for combination products - https://lnkd.in/ecJsV_F #GlobalAccess2026 #IrishMedtech #CombinationProducts #Medtech #Biopharma #RegulatoryAffairs #MedicalDevices #HealthcareInnovation #LifeSciences

𝗗𝗶𝗴𝗶𝘁𝗮𝗹 𝗵𝗲𝗮𝗹𝘁𝗵 𝗶𝘀 𝗮𝗱𝘃𝗮𝗻𝗰𝗶𝗻𝗴 𝗿𝗮𝗽𝗶𝗱𝗹𝘆. 𝗜𝘀 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻 𝗸𝗲𝗲𝗽𝗶𝗻𝗴 𝗽𝗮𝗰𝗲 𝘄𝗶𝘁𝗵 𝘁𝗵𝗲 𝘁𝗿𝘂𝘀𝘁 𝗰𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲? As healthcare systems face growing pressure, digital technologies are creating new opportunities to improve access to care, enhance patient outcomes and support more sustainable healthcare delivery. But technology alone is not enough. Adoption depends on trust. Join us at Global Access 2026 for 𝗗𝗶𝗴𝗶𝘁𝗮𝗹 𝗧𝗿𝘂𝘀𝘁: 𝗪𝗵𝗮𝘁 𝘁𝗵𝗲 𝗥𝗶𝘀𝗲 𝗼𝗳 𝗗𝗶𝗴𝗶𝘁𝗮𝗹 𝗛𝗲𝗮𝗹𝘁𝗵 𝗠𝗲𝗮𝗻𝘀 𝗳𝗼𝗿 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻𝘀, moderated by Mike Cody of Stryker. Bringing together perspectives from regulators, notified bodies, industry, and digital health leaders, this panel will explore how Europe can build a trusted digital health ecosystem while supporting innovation, competitiveness and better patient outcomes. The discussion will examine the regulatory and policy landscape shaping digital health, from AI governance and health data to cybersecurity, regulatory coherence and the practical challenges of adopting digital health technologies at scale. Join us in Galway next week and be part of the discussion shaping the future of trusted digital healthcare - https://lnkd.in/ecJsV_F #GlobalAccess2026 #IrishMedtech #DigitalHealth #Medtech #RegulatoryAffairs #AI #Cybersecurity #HealthInnovation #MedicalDevices

Enter the Irish Medtech Awards today! To stand out the ‘Talent Strategy Award’ entrants for the #IrishMedtechAwards must demonstrate their organisational talent plan, leadership buy-in, evidence of success, and more. The winners will be announced at #MedtechRising co-hosted by Ibec’s Irish Medtech, Enterprise Ireland, and IDA Ireland, 2-3 December, in The Galmont, Galway. Enter here https://lnkd.in/eqGRkGGa

Are you the Medtech Company of the Year? To stand out the ‘Company of the Year’ at the #IrishMedtechAwards must demonstrate strategic vision, innovation complexity, impact for the customer, and more. The winners will be announced at #MedtechRising co-hosted by Ibec’s Irish Medtech, Enterprise Ireland, and IDA Ireland, 2-3 December, in The Galmont, Galway. Enter here https://lnkd.in/eX5TMrxM

We are pleased to announce that due to popular demand the #IrishMedtechAwards deadline has been extended to the 16 October. Enter today here: https://lnkd.in/e7gNa3ny   Read about the Irish Medtech Awards 2025 winners in the special supplement published in the Irish Independent online here: https://lnkd.in/dm99ShGj   Find out more about #MedtechRising co-hosted by Ibec's Irish Medtech, Enterprise Ireland, and IDA Ireland here www.medtechrising.ie

Irish Medtech, along with members of our Ibec Digital Health Working Group (incl. Technology Ireland, BioPharmaChem Ireland members) were delighted to participate in the Al Summit in Dublin today, bringing together global leaders to discuss how #Al can drive economic growth, productivity and industrial leadership across Europe. Taking place during the Irish Presidency of the Council of the EU 2026, the summit reflects Ireland's commitment to supporting collaboration across Europe on the adoption of ethical and trusted Al. Under the theme "Harnessing Al to Revolutionise Europe's Competitiveness", discussions were focused on three strategic themes: • Applied Al and Sectoral Value Creation • Infrastructure: Building Europe's Al Capacity • The Al Opportunity Ahead Speaking on AI Transforming Health: From Discovery to Patient Care were; Belén Fraile (Johnson & Johnson), Emmanuel Frenehard (Sanofi), Dr. Nora K. (Nuritas), Sid Thekkepat (Novartis), with Founders and scaling healthtech companies represented by Donal O'Shea (Deciphex). Well done to all involved in putting on such an impressive showcase of Ireland’s current capability and future ambition💪🏻🇮🇪🇪🇺 Many of the themes & challenges discussed at today’s Summit are addressed in our Generative AI for Medtech – The 2027 Playbook launched last week. In the Playbook Irish Medtech Skillnet, Irish Medtech with lead authors, Brightbeam were pleased to partner with a selection of our member companies on this initiative, which directly supports Skillnet Ireland broader objective of accelerating digital and AI adoption across Irish enterprise through our Business Networks. You can access a copy of the Gen AI Roadmap below; https://lnkd.in/eeXe2cAj

𝗙𝗿𝗼𝗺 𝗟𝗮𝘁𝗶𝗻 𝗔𝗺𝗲𝗿𝗶𝗰𝗮 𝘁𝗼 𝗔𝘀𝗶𝗮-𝗣𝗮𝗰𝗶𝗳𝗶𝗰, 𝘁𝗵𝗲 𝗠𝗶𝗱𝗱𝗹𝗲 𝗘𝗮𝘀𝘁, 𝗔𝗳𝗿𝗶𝗰𝗮, 𝘁𝗵𝗲 𝗨𝗞 𝗮𝗻𝗱 𝗦𝘄𝗶𝘁𝘇𝗲𝗿𝗹𝗮𝗻𝗱, 𝗷𝗼𝗶𝗻 𝘂𝘀 𝗳𝗼𝗿 𝗮 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝘁𝗿𝗶𝗽 𝗮𝗿𝗼𝘂𝗻𝗱 𝘁𝗵𝗲 𝗴𝗹𝗼𝗯𝗲. 𝗜𝗻 𝟲𝟬 𝗺𝗶𝗻𝘂𝘁𝗲𝘀, 𝗼𝘂𝗿 𝗲𝘅𝗽𝗲𝗿𝘁𝘀 𝘄𝗶𝗹𝗹 𝗲𝘅𝗽𝗹𝗼𝗿𝗲 𝘁𝗵𝗲 𝘁𝗿𝗲𝗻𝗱𝘀, 𝗰𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 𝗮𝗻𝗱 𝗼𝗽𝗽𝗼𝗿𝘁𝘂𝗻𝗶𝘁𝗶𝗲𝘀 𝘀𝗵𝗮𝗽𝗶𝗻𝗴 𝗺𝗮𝗿𝗸𝗲𝘁 𝗮𝗰𝗰𝗲𝘀𝘀 𝗮𝗰𝗿𝗼𝘀𝘀 𝗶𝗻𝘁𝗲𝗿𝗻𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗺𝗮𝗿𝗸𝗲𝘁𝘀. Join us at Global Access 2026 for 𝗔 𝗦𝗻𝗮𝗽𝘀𝗵𝗼𝘁 𝗼𝗳 𝗜𝗻𝘁𝗲𝗿𝗻𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗧𝗿𝗲𝗻𝗱𝘀, moderated by Tommy McDonagh, Associate Director Regulatory Affairs at Abbott. This session will explore evolving regulatory frameworks, emerging regional priorities, and the implications for market entry, product registration and lifecycle management. Attendees will gain practical insights into how regulatory intelligence can drive strategic decision-making and support successful global market access strategies. As regulatory complexity continues to grow across international markets, organisations that can anticipate change and adapt their regulatory strategies will be best positioned to support innovation, business growth and timely patient access. Book your ticket now and gain practical insights into the international regulatory trends shaping the future of global market access - https://lnkd.in/ecJsV_F #GlobalAccess2026 #IrishMedtech #RegulatoryAffairs #Medtech #MarketAccess #MedicalDevices #RegulatoryStrategy #InternationalRegulation #QualityAssurance