MedTech Intelligence

Planes, trains, and device regulation – the fatigue of regulatory challenges: MTI REGULATORY REPORT 2024 (part 1) https://lnkd.in/ejMkzhDn MTI Regulatory Report 2024 data overwhelmingly suggests industry-wide regulatory fatigue driven by changing global compliance regulations in recent years. Regulatory resources throughout the industry are being stretched and demand for regulatory intelligence necessary to remain compliant, competitive, and profitable is a growing priority. See the 1st article in our series from the recent research by MedTech Intelligence and Celegence. Rich West Rick Biros Punya Abbhi Rachel Hollos Owen Jones ACIM Dr. Pratibha Mishra Ibim Tariah Erin Cosgrove

Planes, trains, and device regulation – the fatigue of regulatory challenges: MTI REGULATORY REPORT 2024 (part 1) https://lnkd.in/ejMkzhDn MTI Regulatory Report 2024 data overwhelmingly suggests industry-wide regulatory fatigue driven by changing global compliance regulations in recent years. Regulatory resources throughout the industry are being stretched and demand for regulatory intelligence necessary to remain compliant, competitive, and profitable is a growing priority. See the 1st article in our series from the recent research by MedTech Intelligence and Celegence. Rich West Rick Biros Punya Abbhi Rachel Hollos Owen Jones ACIM Dr. Pratibha Mishra Ibim Tariah Erin Cosgrove

In the light of new Medical Device market research, Peter Muller and Mike Baird of Schlafender Hase assess how well Class 2 and 3 device manufacturers in Europe and the US are adapting to a rise in regulatory controls here in MedTech Intelligence. https://lnkd.in/gW8F3Xet. Thanks to Rick Biros and Rich West #medicaldevice #regulatory #TVT #medtech

⏰Last Chance – webinar registration is closing soon. Get leading insights on "𝐌𝐚𝐧𝐚𝐠𝐢𝐧𝐠 𝐆𝐥𝐨𝐛𝐚𝐥 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐲 𝐚𝐧𝐝 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞: 𝐀𝐬𝐬𝐞𝐬𝐬𝐢𝐧𝐠 𝐒𝐭𝐚𝐭𝐮𝐬, 𝐆𝐚𝐩𝐬, 𝐚𝐧𝐝 𝐍𝐞𝐞𝐝𝐬" from notified bodies, regulatory management & maintenance experts! 📅 July 31, 2024 | 🕙 12:00 PM ET US 𝐏𝐚𝐧𝐞𝐥𝐢𝐬𝐭𝐬: Dr. Pratibha Mishra, Senior Manager – Medical Device Services Erin Cosgrove, VP, Business Development – Medical Devices Ibim Tariah, Technical Director, Medical Devices, SGS Gregory Jacobson, Sales Director – Medical Devices, SGS 𝐌𝐨𝐝𝐞𝐫𝐚𝐭𝐞𝐝 𝐛𝐲: Rich West, Editorial Director & Publisher, MedTech Intelligence 𝐊𝐞𝐲 𝐋𝐞𝐚𝐫𝐧𝐢𝐧𝐠 𝐎𝐛𝐣𝐞𝐜𝐭𝐢𝐯𝐞𝐬 ▶𝐈𝐝𝐞𝐧𝐭𝐢𝐟𝐲 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐆𝐚𝐩𝐬: Understand why gaps in regulatory intelligence and compliance processes are overwhelming for teams and organizations. ▶𝐑𝐢𝐬𝐤 𝐌𝐢𝐭𝐢𝐠𝐚𝐭𝐢𝐨𝐧: Learn strategies to mitigate risks associated with the growing complexities of global regulatory compliance. ▶𝐅𝐨𝐜𝐮𝐬 𝐀𝐫𝐞𝐚𝐬: Discover where to prioritize MDR/IVDR efforts and investments. ▶𝐓𝐞𝐜𝐡𝐧𝐨𝐥𝐨𝐠𝐲 𝐚𝐧𝐝 𝐑𝐞𝐬𝐨𝐮𝐫𝐜𝐞𝐬: Explore technologies and resources for cost-effective management of current bandwidth limitations in the industry. 𝐀𝐥𝐥 𝐫𝐞𝐠𝐢𝐬𝐭𝐞𝐫𝐞𝐝 𝐚𝐭𝐭𝐞𝐧𝐝𝐞𝐞𝐬 𝐰𝐢𝐥𝐥 𝐫𝐞𝐜𝐞𝐢𝐯𝐞 𝐭𝐡𝐞 𝐫𝐞𝐜𝐨𝐫𝐝𝐞𝐝 𝐬𝐞𝐬𝐬𝐢𝐨𝐧 𝐚𝐟𝐭𝐞𝐫 𝐭𝐡𝐞 𝐞𝐯𝐞𝐧𝐭, 𝐬𝐨 𝐛𝐞 𝐬𝐮𝐫𝐞 𝐭𝐨 𝐫𝐞𝐠𝐢𝐬𝐭𝐞𝐫 𝐧𝐨𝐰: https://lnkd.in/gX8g33mW #MedTech #Webinar #RegulatoryCompliance #MedicalDevices #MDR #IVDR #RegulatoryIntelligence #Regulatory #RegulatoryAffairs

Regulatory fatigue...a concern voiced in recent MTI audience polling, and an issue we're hearing more and more medical device regulatory affairs teams voice. Join our panel of regulatory SMEs as they unpack recent survey data on regulatory strategy, compliance management, and MDR/IVDR maintenance, plus insights into current technologies, resources and regulatory cost management. https://lnkd.in/gX8g33mW Celegence SGS Punya Abbhi Dr. Pratibha Mishra Erin Cosgrove Ibim Tariah, Gregory Jacobson Rich West

Medical device industry regulatory resources are strained! Fewer than 1/4 of MTI readers say they have the needed resources for all 2024 priorities. A recent survey shines a light on where the priorities remain. Join our expert regulatory panel for guidance to help assess your gaps, prioritize your needs, manage your regulatory resources, and recognize how & when to engage technologies and outside expertise.

Join us on July 18 for a webinar with MedTech Intelligence, "Now that the EU MDR deadline is passed, how do you sell your device abroad?" Ibim Tariah, Ph.D., Technical Director - Medical Devices, will be joined by Gregory Jacobson, Sales Director - Medical Devices, to discuss alternative avenues to selling devices abroad now that the EU MDR deadline has passed. Learn strategies that will help you to navigate other options such as MDSAP, UKCA Marking, and Swissmedic Approval. Register here: https://bit.ly/3XN3cU5 #MedicalDevices #MDR #MDD #SGSNorthAmerica

Information polarization affects public opinion and investors. As we approach upcoming elections in different countries, it is crucial to understand how these political events could significantly reshape the landscape for MedTech investments. In this article, Ashkan Eliasy outlines an approach to help investors navigate and understand the interplay of political climates, cultural norms, and healthcare policies without getting emotionally attached to them. It also emphasizes the importance of open dialogue, diversity, critical thinking, and cross-cultural collaborations to determine the true potential of #MedTech innovations. #medtechinvesting

🔍 𝐃𝐨 𝐲𝐨𝐮 𝐤𝐧𝐨𝐰 𝐭𝐡𝐞 𝐌𝐚𝐧𝐝𝐚𝐭𝐨𝐫𝐲 𝐂𝐫𝐢𝐭𝐞𝐫𝐢𝐚 𝐟𝐨𝐫 𝐏𝐨𝐬𝐭-𝐌𝐚𝐫𝐤𝐞𝐭 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐅𝐨𝐥𝐥𝐨𝐰-𝐔𝐩 (𝐏𝐌𝐂𝐅) 𝐮𝐧𝐝𝐞𝐫 𝐭𝐡𝐞 𝐄𝐔 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐨𝐧 (𝐄𝐔𝐌𝐃𝐑)?  🎥 In our comprehensive webinar hosted in partnership with @MTI, industry experts Parvathi Nambiar and Smridula Hariharan, delve into the essential criteria that necessitate PMCF, including scenarios involving novel technologies, devices used in high-risk populations, or where long-term safety and performance data are unclear. This in-depth session offers valuable insights into navigating these regulatory waters with confidence. 🌐 Access the full on-demand webinar and gain crucial knowledge to ensure compliance with the evolving EUMDR: https://lnkd.in/gbskJ7ff 𝐊𝐞𝐲 𝐇𝐢𝐠𝐡𝐥𝐢𝐠𝐡𝐭𝐬 𝐈𝐧𝐜𝐥𝐮𝐝𝐞:  ▶ Detailed exploration of scenarios that mandate PMCF, helping you identify when your device must comply.   ▶ Strategies for crafting effective PMCF plans that address regulatory requirements and ensure device safety and efficacy.   ▶ Cost-effective approaches to conducting PMCF, utilizing real-world data and existing resources for comprehensive oversight.   ▶ Expert advice on overcoming common PMCF planning and execution challenges, equipped with real-world examples and actionable tips. Embrace the expertise and tailored solutions from Celegence as you navigate the complexities of medical device regulations. Our team is ready to boost your strategic capabilities, ensuring you meet the demands of #medicaldeviceregulation and #EUMDRcompliance with ease. #medicaldevices #regulatoryaffairs #compliance #regulatorystrategy #EUregulation #medtech #webinars #healthcarecompliance #medicalregulation #EUpolicy #regulatoryinsights #clinicaldata #postmarketsurveillance #Celegence #medtech #PMCF #EUMDR  #MedicalDeviceRegulation #PostMarketSurveillance #MedicalDevices #RegulatoryAffairs #MedicalCompliance #MedTechInnovation #HealthcareRegulation #ClinicalDataManagement #MedicalDeviceCommunity #RegulatoryStrategy #MedicalSafety #ClinicalEvaluation #RegulatoryCompliance 

🔔 Impact of #AIAct on the medical and healthcare sector #MDR 🔔 Join the conversation today at 16:00 CET https://lnkd.in/e92RZ9Yq