Barr is a proud sponsor of the EHS for Diagnostic & Medical Devices Summit, and we are excited to announce our upcoming attendance! Join us on July 18 at 9:30 a.m. to see Adam Driscoll’s presentation and discussion on PFAS regulations and developments within the medical field. #PFAS #EnvironmentalRegulations #Technology
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Stay informed about FDA updates to the Breakthrough Devices Program by checking out our latest blog post! This Program helps expedite development and review of eligible medical devices while ensuring their safety and efficacy. Take a look at our helpful breakdown of how devices might qualify for this pathway. Healthcare Innovators - is this program right for your technology? BMTA can assist you in navigating this and other potential paths in the evolving landscape of medical device regulation. #BMTA #FDA #BreakthroughDevices #MedicalDevices #HealthcareInnovation #TechRegulation
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Invent Medical Corporation Receives the FDA 510(k) clearance for its HFT150® High Flow System Invent Medical Corporation is pleased to announce the FDA 510(k) clearance on their HFT150® high flow system. Sam Chang, CEO, comments, "After several years in development and based on multiple key opinion leaders' input on product design and features, we are launching the HFT150® high flow system, featuring patented proprietary platform technology into the USA hospital markets in the fall of 2024. Based on feedback from respiratory care practitioners and pulmonologists, we believe we have designed a world-class product that solves many of today's problems with current technologies in the high-flow market." A recent market report shows that the growth of the heated high-flow market sector is expected to outpace that of other respiratory devices. #inventrespiratory #highflowsystem #fdaclearance
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🛑 What's the impact of the upcoming PFAS restrictions on medical device manufacturers and what are the regulatory considerations? Here's a short clip from Jaishankar Kutty, Ph.D. addressing those aspects, but there will be 𝙘𝙤𝙣𝙨𝙞𝙙𝙚𝙧𝙖𝙗𝙡𝙮 more information of value shared in next week's RQM+ Live! presentation and panel... 𝗘𝘅𝗶𝘁𝗶𝗻𝗴 𝗣𝗙𝗔𝗦: 𝗔 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝗰 𝗕𝗹𝘂𝗲𝗽𝗿𝗶𝗻𝘁 𝗳𝗼𝗿 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗠𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗲𝗿𝘀 Please RSVP 🎟️ for Thursday's event in the comments! All who let us know they're coming will be emailed the slides presented, as well as bonus content. #MedTech #PFAS
PFAS: Impact on Device Manufacturers and Regulatory Considerations
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Acheteur expert filière biomédical au Ministère de la santé Tunisie chez UGPO des Projets de Santé Financés par des Dons et des Prêts Extérieurs
New MDCG documents published: MDCG 2024-6 - Preliminary assessment review (PAR) form template (MDR) MDCG 2024-7 - Preliminary assessment review (PAR) form template (IVDR) MDCG 2024-8 - Preliminary re-assessment review (PRAR) form template (MDR) MDCG 2024-9 - Preliminary re-assessment review (PRAR) form template (IVDR) These documents aim to ensure that Notified Bodies maintain high standards of operation, independence, impartiality, and competence, which are critical for the safety and efficacy of medical devices in the European market.
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The KiiP Wicked Stability project is working on a study to evaluate stability data of commonly used #medicaldevice packaging materials, with the aim of reducing testing and saving time. Ultimately, they hope to impact the industry by showing that commonly used sterile barrier systems are inherently stable after years of aging studies. Now, they're seeking industry collaboration. In an effort led by Jennifer Benolken, CPPL and Wendy Mach, the intent is to have medical device manufacturers submit data from various stability testing that they've performed on commonly used medical device packaging materials for sterile barrier systems. Data will be scrubbed of any identifying information, with analysis performed by independent labortatory Canyon Labs. (Participants must complete a confidentiality agreement to participate.) Submit your data between now and November 30, 2024, to contribute to this analysis. #stability #healthcarepackaging #regulatory
MDMs: Submit Stability Data, Help Packaging Science!
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Continuing with "Basil's Regulatory Roundup: Annual Insights Across Panels," this post we delve into the heart of medical innovation – the Cardiovascular panel. Over the past year, we've witnessed substantial momentum in the cardiovascular sector with a heartening 321 new 510(k) clearances, 6 innovative De Novo approvals, and a striking 22 PMA approvals, accompanied by a significant 1,092 PMA supplements – evidence of a field pulsating with advancements. Dominating the product code clearances are advanced measuring systems, diagnostic computers, and essential tools like percutaneous and continuous catheters – each playing a critical role in enhancing patient diagnostics and care. Join us as we continue to unveil the layers of regulatory insights across various panels, here on "Basil's Regulatory Roundup." #Cardiovascular #MedicalDevices #FDAApproval #MedTech #RegulatoryAffairs #fdacleared
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RQM+'s innovative approach to 𝗣𝗼𝘀𝘁-𝗠𝗮𝗿𝗸𝗲𝘁 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗙𝗼𝗹𝗹𝗼𝘄-𝘂𝗽 (𝗣𝗠𝗖𝗙) studies can significantly reduce the burden of adverse event reporting for medical device manufacturers. Our brand new technical brief co-authored by Niki Caporali Spaniel, RAC and Anastassia Young, MS dives into the FDA's exemptions and variances process, showcasing how we streamline reporting requirements and leverage real-world evidence to enhance device safety and performance. Learn more about the strategic value of PMCF studies and how RQM+ is leading the way. 📖💡 https://lnkd.in/e-FTwntb #MedicalDevices #PMCF #FDARegulations #MedTech
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🖐 Welcome to IVDR TALK 4! Last summer, the MDCG paper 2022-14 attracted much attention. The working group highlighted a critical concern: the need for sufficient notified body capacity, which is proving to be a key and time-critical hurdle for the certification of medical devices and IVDs under the MRD and IVDRD regulations during the transition phases. To find solutions, the Medical Device Coordination Group has outlined a strategic roadmap in this document that identifies actionable measures to build the capacity of Notified Bodies, simplify access and improve manufacturer readiness. Find out how TÜV SÜD has addressed these challenges and share your thoughts with our experts Marta Carnielli and Andreas Stange! 💬 #medicaldevicecertification #ivdr #mdr #notifiedbodies #tuvsud
IVDR Talk 4: How Notified Bodies respond to MDCG 2022-14 actions
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During medical devices development, both safety and efficacy are paramount. At the core of this pursuit lies the Biological Evaluation Report (BER), a comprehensive documentation that serves to assess and validate the device biocompatibility. Learn more about our solutions for the biocompatibility evaluation! #BiologicalEvaluationReport #MedicalDevices #PatientSafety #RegulatoryCompliance #HealthcareInnovation #WeAreULSolutions
Medical Device Biocompatibility Testing
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During medical devices development, both safety and efficacy are paramount. At the core of this pursuit lies the Biological Evaluation Report (BER), a comprehensive documentation that serves to assess and validate the device biocompatibility. Learn more about our solutions for the biocompatibility evaluation! #BiologicalEvaluationReport #MedicalDevices #PatientSafety #RegulatoryCompliance #HealthcareInnovation #weareULSolutions
Medical Device Biocompatibility Testing
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