MassMEDIC

With only one week until our Regulatory Roundup on Nov. 13, hosted by Arena by PTC, and with only 10 in-person tickets left, now is the time to register! As a subscriber to our LinkedIn page, use code "READ+10" (no quotes) to save an EXTRA $10 off our current best promo for a total savings of $40! https://bit.ly/4cmSvML The premiere regulatory event for medtech professionals in the Northeast, the Regulatory Roundup is designed to give RA, QA and C-level executives updates on the global and domestic regulatory issues facing the industry, The agenda includes comprehensive presentations by FDA officials, including the newly appointed Director of the Center for Devices and Radiological Health, Dr. Michelle Tarver, industry representatives and regulatory experts. We only have 10 in person tickets left, so register now to secure your place!

There's still time to join us next week at the Regulatory Roundup, hosted by Arena by PTC! Designed to give RA, QA and C-level executives updates on the global and domestic regulatory issues facing the industry, the agenda includes comprehensive presentations by FDA officials, industry representatives and regulatory experts. Featuring a keynote and Q&A with the new Director of the Center for Devices and Radiological Health, FDA, Dr. Michelle Tarver, and a full day of content, including "Stories from the Front Lines" where you'll hear from industry regarding what is keeping them up at night! Hear from Marie Buharin, Director, Regulatory Affairs, Medtronic, Chris Cain, VP, Clinical & Regulatory Affairs, Hyalex Orthopaedics Inc., Mrunmayee Satam, Director of Quality and Regulatory Affairs, Podimetrics, and Sharon Timberlake, VP of Clinical, Quality, & Regulatory Affairs, Gentuity, LLC, this roundtable discussion will highlight the pain points and opportunities those working on the "front lines" are experiencing, including best practices and lessons learned. Only 10 in-person tickets remain. Get yours now! https://bit.ly/4cmSvML #medtech #regulatory #compliance #quality #fda #cdrh

Time is running out to get your tickets for the Regulatory Roundup on November 13! Don't miss out on access to Dr. Michelle Tarver, newly confirmed director for the Center for Devices and Radiological Health, FDA, who will provide a #keynote on the organization's priorities for 2025 and beyond. Following the keynote, live attendees will get to participate in a Q&A with Dr. Tarver, moderated by Veeva MedTech. The full day includes many other important discussions on regulatory topics of importance to medtech, as well as meals, snacks and time for networking with industry peers. Secure your spot now: https://bit.ly/3YrsG8b #meddevice #regulatory #medtech #guidance #registernow

Happy Halloween from the MassMEDIC team! Starting and growing your #medtech company can be scary if you go it alone. Our team is here to support you in connecting to the heart of heathtech, tapping into resources, contacts and #education relevant to your business needs. Comment below or contact us today at info@massmedic.com to learn more! #heartofhealthtech #connection #awarness #advocacy

If you haven't yet registered, you have one more week to do so before "AI-Driven Innovation: Transforming MedTech for Manufacturers with Quebec’s Leading Solutions" from our friends at the Délégation du Québec à Boston (DQB) on Nov. 7 at 1 pm ET. https://bit.ly/3YvKgcq #Quebec is rapidly emerging as a global leader in #AI, driven by a thriving ecosystem of academic research, government support, and innovative companies. This AI expertise is playing a pivotal role in advancing industries like #medtech, where AI solutions are transforming manufacturing processes by optimizing operations, improving product quality, and meeting regulatory requirements in a highly competitive market. Attendees will learn: ⭐ How to build out digital, intelligent supply chain processes that protect brand and product integrity with minimal disruption to production lines. ⭐ How integrating AI models can improve operational efficiency. ⭐ How Québec has federated government actors, research institutions, and private sector partners to accelerate their AI ecosystem in the medtech sector Don’t miss this opportunity to discover how Quebec’s AI-driven innovations can propel your organization forward and improve your manufacturing processes.

There's only three weeks until our Regulatory Roundup on Nov. 13, hosted by Arena by PTC. With only about 20-in person spots left, don't miss out on this opportunity to receive updates on the global and domestic regulatory issues facing the #medtech industry. https://bit.ly/4cmSvML One topic on the agenda is “Insights into the Development of IEC 60601-1 4th Edition,” presented by Yaqing Liu, Global Chief Engineer, Medical and Mike Brousseau, Regional Chief Engineer, Medical, of Intertek. As the primary global standard for electrical safety in medical devices, they'll discuss how IEC 60601-1 has undergone numerous changes, with the upcoming 4th edition set to bring the most significant updates in nearly 20 years. Yaqing and Mike will dive into a behind-the-scenes look into the development of this critical standard, providing attendees with early insights into key topics being discussed, some potential changes that could impact regulatory and compliance pathways, and how manufacturers can start preparing now for the upcoming revisions. This session is essential for anyone involved in the #design, #manufacturing, or #testing of medical devices, offering a roadmap to navigating new #compliance requirements most effectively.

We are proud to partner with @Medical Device Manufacturers Association (MDMA) to support their upcoming 2024 Reimbursement & Health Policy Conference in Washington, DC November 13-14th. Featuring industry experts discussing practical insights on reimbursement strategy and execution as well as an exciting lineup of panels with speakers from industry and government, don't miss this great opportunity for reimbursement, market access, and health policy professionals! Time is running out, so be sure to view the agenda and register today! https://bit.ly/4ddx0xy MassMEDIC members! Save $100 on MDMA non-member rates for this event with code STATE.

Don't wait! Register now for the region's premiere regulatory program, our Regulatory Roundup on Nov. 13th, hosted by Arena by PTC. https://bit.ly/4cmSvML Designed to give RA, QA and C-level executives updates on the global and domestic regulatory issues facing the industry, the agenda includes comprehensive presentations by FDA officials, industry representatives and regulatory experts. Erez Kaminski, Founder and CEO of Ketryx, will be sharing a presentation on the FDA's Predetermined Change Control Plan (PCCP) guidance and what it means for the industry. His talk will present strategies and case studies to aid in the design of medical device infrastructures with PCCPs in mind, enabling companies to surpass competitors stuck in traditional regulatory frameworks. Learn a practical and systematic approach to designing, constructing, and validating a successful PCCP. Implementing these strategies will lead to faster releases and, ultimately, safer systems. Which would you prefer: version 2 of a pacemaker or version 50? By leveraging PCCPs for ongoing enhancements, medtech companies can deliver effective changes for better patient and business outcomes.

#Quebec is rapidly emerging as a global leader in #AI, driven by a thriving ecosystem of academic research, government support, and innovative companies. This AI expertise is playing a pivotal role in advancing industries like #medtech, where AI solutions are transforming manufacturing processes by optimizing operations, improving product quality, and meeting regulatory requirements in a highly competitive market. Join us to learn more about these AI-driven innovations with this free webinar, "AI-Driven Innovation: Transforming MedTech for Manufacturers with Quebec’s Leading Solutions" from our friends at the Délégation du Québec à Boston (DQB) on Nov. 7 at 1 pm ET. https://bit.ly/3YvKgcq Don’t miss this opportunity to discover how Quebec’s AI-driven innovations can propel your organization forward and improve your manufacturing processes.

Thank you to everyone who joined us Monday for our first Patient Engagement Congress, hosted by Abiomed, part of Johnson & Johnson MedTech and sponsored by Alira Health! With close to 100 in attendance, the sold-out event shared innovative best practices and lessons learned from existing patient engagement programs to help attendees develop strategy and tactics around building their own. Thank you to all of our speakers who took the time to share their expertise! Pepi Hurtado-Lopez, Managing Partner, Global Market Access & Pricing, Alira Health; Leah LaRose, Manager, Orthopedics Patient Marketing, DePuy Synthes, Johnson & Johnson Medtech; Maria Restrepo, Ph.D., Diversity in Clinical Trials Program Director, Medtronic; Melissa Schooley, Esq., Vice President, Global HEMA & GA, Abiomed, part of J&J MedTech; Shannon Kjellsen, Associate Director, Patient Advocacy, Abiomed, Part of J&J MedTech; Andrea Conley, MBA, Head of Patient Services, Lantheus; Elizabeth Hamacher, Vice President of Clinical Services & Support, Podimetrics, and Mira Sahney, Medtech Executive, Past President, Pelvic Health, Medtronic. An extra special thank you goes to all of our inspiring patient advocates who joined us to share their stories, including Rachelle Jaymeson, Impella patient, Abiomed, part of Johnson & Johnson MedTech; Justin Kelly, BSN, RN, SVP, Patient Access, Noctrix Health, Inc. and colon cancer survivor; Matt Cruise, Territory Manager, Neuromodulation, Boston Scientific and EMBLEM S-ICD System patient and Mike Hugo, Patient Advocate, Medtronic and Glioblastoma Patient Thriver, Optune GIO, Novocure. This is just the start of these important conversations on how to more effectively engage and support patients in the #medtech industry. Stay tuned for future opportunities to get involved! #patientengagement #patientadvocacy #knowbetterdobetter