Glenn Wanke’s Post

⁉ DID YOU KNOW - The EU AI Act is reshaping the regulatory landscape for medical device manufacturers, and it's time to ensure your compliance strategy is on point. With the recent approval by the European Parliament, this game-changing legislation underscores the importance of safety, transparency, and rights compliance in AI technology. Stay ahead of the curve and partner with TÜV Rheinland to navigate the regulatory effectively. Let's secure your future success together! #EUAIAct #MedicalDevices #RegulatoryCompliance #Innovation #AI #TÜVRheinland

As the year draws to a close, I wanted to share my insights in Med-Tech Innovation about the pivotal regulatory changes for medical devices and IVDs in the UK and EU this year. From extended transitional periods for CE-marked devices in the UK to the EU’s adoption of the AI Act, 2024 has been a transformative year for the regulatory landscape. With evolving frameworks and a focus on AI in medical devices, manufacturers face the challenge of balancing innovation with compliance. Discover how these changes could shape your business: https://lnkd.in/ebwKRtmR #MedTech #RegulatoryCompliance #Innovation #AI #RegulationMadeSimple Oliver Johnson

AI Regulations: A Priority for Medical Device Manufacturers Understanding and adapting to the regulatory landscape surrounding AI is not just beneficial, but crucial for future success. https://lnkd.in/e5MPEARJ

AI Regulations: A Priority for Medical Device Manufacturers Understanding and adapting to the regulatory landscape surrounding AI is not just beneficial, but crucial for future success. https://lnkd.in/e5MPEARJ

It’s been almost 20 years since the FDA approved its first AI/ML-enabled medical device – and wow, things have evolved since then. Explore some of the latest advancements in our blog: https://bit.ly/3QL4PwI #ArtificialIntelligence #MachineLearning #MedicalDevices

As the year draws to a close, Laura Friedl-Hirst, Founder and Managing Director at LFH Regulatory Limited, shares her insights in Med-Tech Innovation about the pivotal regulatory changes for medical devices and IVDs in the UK and EU this year. From extended transitional periods for CE-marked devices in the UK to the EU’s adoption of the AI Act, 2024 has been a transformative year for the regulatory landscape. With evolving frameworks and a focus on AI in medical devices, manufacturers face the challenge of balancing innovation with compliance. Discover how these changes could shape your business: https://lnkd.in/eqpvf_Qn #MedTech #RegulatoryCompliance #Innovation #AI #RegulationMadeSimple Olivia Friett Oliver Johnson

Fruitful partnerships fostering innovation and everyday working to simplify and regulatory affairs for medical devices manufacturers! Follow us to stay up-to-date. Medtiles João Reis #ai #tech #digitalhealth #generativeai #genai #genaihealthcare #medtech #regulatoryaffairs #medicaldevices

Exciting news! We’re hosting a webinar on AI & Structured Data and how it’s boosting efficiency in medical device manufacturing. On October 15th at 11am, come join experts as they share real-world examples of AI driving process automation while ensuring compliance with global regulations!

Interesting list of asks from MedTech Europe when it comes to clarification needed regarding the #aiact. If you work for the #medtech sector, what concerns you most: 1️⃣ Whether devices in clinical investigations will need to be CE marked; 2️⃣ Whether a single conformity assessment is possible under the #EUMDR or #EUIVDR and the AI Act including use of the same notifeid body; or 3️⃣ The avoidance of duplication or conflict of standards written in the context of the AI Act with EU harmonized medtech standards? https://bit.ly/43zIfND

⚠️ 🚧Legislative coherence is needed to provide legal certainty for #medtech: Medical Devices and Diagnostics that contain #ai need to comply now with the new horizontal 🇪🇺 #AIAct. That comes in addition to the existing sector specific 🇪🇺#MDR and #IVDR which already includes specific requirements for digital MDs. Manufacturers need to comply with both laws. That raises pragmatic questions on how to do it without duplication and delay. Future #guidance will hopefully bring swift clarification 🍀. #innovation #digitalhealth