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Volume 15 Issue No. 21 |
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By MedTech Intelligence Staff At Device Talks Boston in May, Ronald Kurz, Sr. Director and GM at Canon Virginia, Kathryn Unger, Sr. Mgr. of Global ESG Communications at Boston Scientific, and David Ettl, COO at Gradian Health System, addressed the question, how can we make medical products sustainable? |
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| Featured Articles |
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MedDesign Wearable Design Challenge: By Bret Ludwig, Ph.D., 3M An adhesive developer explains why skin is so challenging to adhere to, why it’s never too early to explore skin-adhesive options for your wearable device, and recent milestones in stick-to-skin adhesive longevity. |
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COMPLIMENTARY ON DEMAND WEBINAR |
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Sponsored By Rimsys Regulatory Management Software Most MedTech companies treat regulatory affairs as an operational cost center, which prevents them from realizing the potential of a bigger-picture regulatory strategy and creates friction between regulatory and go-to-market teams. In this webinar, Bruce McKean, Director of Regulatory, and James Gianoutsos, Founder and CEO, of Rimsys Regulatory Management Software, share how improved regulatory performance can speed time to market, reduce operational costs and help companies capture market share when new regulations are implemented. |
Regulatory Strategy as Competitive Advantage|
FDA CDRH Portal Now Offers Tracking of Pre-Submissions By MedTech Intelligence Staff The FDA has updated the CDRH portal to allow users to track the progress of their pre-submissions. As of October 23, 2023, all 510(k) submissions, unless exempted, must be submitted as electronic submissions using FDA’s eSTAR portal. |
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Process and Planning Are Key to Successful EU MDR PMS Compliance By Jonathan Ripley, IMed Consultancy In spite of continuing delays to implementation deadlines for EU MDR/IVDR, post-market surveillance requirements are currently in force. Hence, manufacturers need to urgently establish a PMS system to identify potential nonconformances and safeguard users and patients. |
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Five Critical Considerations for Connected Health Manufacturers By Brad Jolly, Keysight Technologies Internet-enabled medical technologies have significantly improved the standard of care. They have also introduced a range of challenges for healthcare practitioners, administrators, and patients. The good news is these issues can be mitigated—or, in some cases, eliminated—in the engineering and design phase. Following are five key considerations for manufacturers to help foster connected healthcare’s continued acceleration. |
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Featured Quote — Steven Silverman, The Silverman Group |
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| MedTech Library | |
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Sponsored By Veeva Medtech Terumo, global leader in medical technology, transforms to a unified, digital approach to manage global clinical trials and operations. Read this article to learn about the approach, processes, infrastructure changes, and impact on the business. |
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Sponsored By Arrow and Dell Technologies Learn the key considerations and best-fit solutions for healthcare transformation that optimize operations for providers and ensure better outcomes for patients. Discover how the Arrow Electronics and Dell Technologies OEM Solutions portfolio can match any healthcare need. |
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Sponsored By Rimsys The 2023 MedTech Regulatory Performance Report provides insights and process benchmarks from a survey of 200 medtech regulatory professionals across North America and Europe. The report explores regulatory staffing and team size, workload and average times to complete regulatory projects, compliance issues and costs, and the role of technology and digital transformation. |
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Drive Healthcare Transformation with Enterprise-Level Infrastructure
2023 MedTech Regulatory Performance Report
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| Upcoming Events & Webinars |
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June 6, 2023 - 10:00am EDT/4:00pm CEST Mastering EU MDR: |
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June 8, 2023 - 10:00am EDT Not All Medical Products Are Created Equal. |
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MedTech Intelligence 2023 Washington DC Conferences More info at MedTechIntelligence.com November 7-8 November 8-9 November 13-14 |
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