RQM

𝐉𝐨𝐢𝐧 𝐔𝐬 𝐟𝐨𝐫 𝐚𝐧 𝐄𝐬𝐬𝐞𝐧𝐭𝐢𝐚𝐥 𝐃𝐢𝐬𝐜𝐮𝐬𝐬𝐢𝐨𝐧 𝐨𝐧 𝐇𝐞𝐚𝐥𝐭𝐡 𝐄𝐪𝐮𝐢𝐭𝐲 𝐢𝐧 𝐌𝐞𝐝𝐓𝐞𝐜𝐡! 📅 𝐃𝐚𝐭𝐞: Thursday, 8 August 2024 ⏰ 𝐓𝐢𝐦𝐞: 11am ET / 5pm CEST 👉 𝐒𝐢𝐠𝐧 𝐮𝐩: https://lnkd.in/edgnvnQA RQM is excited to host a panel discussion on "𝐀𝐝𝐯𝐚𝐧𝐜𝐢𝐧𝐠 𝐇𝐞𝐚𝐥𝐭𝐡 𝐄𝐪𝐮𝐢𝐭𝐲 𝐰𝐢𝐭𝐡 𝐈𝐕𝐃𝐬 & 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞𝐬." We are honored to welcome Michelle Tarver, MD, PhD, Deputy Center Director for Transformation at FDA, CDRH, along with our esteemed RQM experts. 𝐃𝐢𝐬𝐜𝐮𝐬𝐬𝐢𝐨𝐧 𝐇𝐢𝐠𝐡𝐥𝐢𝐠𝐡𝐭𝐬: 🔍 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐄𝐱𝐩𝐞𝐜𝐭𝐚𝐭𝐢𝐨𝐧𝐬 Gain insights into regulatory efforts and FDA requirements for enhancing diversity in clinical trials. 🏠 𝐇𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐚𝐭 𝐇𝐨𝐦𝐞 Explore the "Home as a Healthcare Hub" initiative and its impact on health equity. 🏢 𝐈𝐧𝐝𝐮𝐬𝐭𝐫𝐲 𝐏𝐞𝐫𝐬𝐩𝐞𝐜𝐭𝐢𝐯𝐞𝐬 Hear from industry leaders on strategies and real-world examples of addressing health equity in #MedTech. 📝 𝐀𝐜𝐭𝐢𝐨𝐧 𝐏𝐥𝐚𝐧𝐬 𝐚𝐧𝐝 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐞𝐬 Learn best practices for developing comprehensive plans to assess diversity and address equity within medical device companies. ❓ 𝐈𝐧𝐭𝐞𝐫𝐚𝐜𝐭𝐢𝐯𝐞 𝐐&𝐀 Engage with our panelists and deepen your understanding of these critical issues. 𝐏𝐚𝐧𝐞𝐥𝐢𝐬𝐭𝐬: • Michelle Tarver, MD, PhD – Deputy Center Director for Transformation, FDA, CDRH • Allison Komiyama, PhD, RAC – Vice President, MedTech Innovations, RQM • Jonathan Gimbel – Vice President of Technical, RQM • Brandy Chittester – Senior Director, Clinical Operations, RQM • Jaishankar Kutty, Ph.D. – Vice President, Global Regulatory Affairs, RQM (Moderator) Don't miss this opportunity to expand your knowledge and network with industry leaders. Register now and receive the slides and recording, even if you can't attend live! 🔗 Sign Up Here: https://lnkd.in/edgnvnQA We look forward to seeing you on the 8th of August! #RQMPlus #HealthEquity #MedTech #IVDs #FDA #Healthcare #MedicalDevices #Webinar #HealthcareInnovation

🔔 𝐒𝐭𝐚𝐲 𝐀𝐡𝐞𝐚𝐝 𝐰𝐢𝐭𝐡 𝐑𝐐𝐌 𝐖𝐞𝐞𝐤𝐥𝐲 𝐖𝐚𝐭𝐜𝐡! Discover the latest insights in the MedTech industry with our RQM Weekly Watch newsletter. Stay informed, stay ahead. 𝐓𝐡𝐢𝐬 𝐰𝐞𝐞𝐤'𝐬 𝐡𝐢𝐠𝐡𝐥𝐢𝐠𝐡𝐭𝐬: 🎉 Allison Komiyama, PhD, RAC is a 2024 Regulatory Affairs Professionals Society (RAPS) Fellow! 🔁 The FDA published a revision to their Application User Fees for Combination Products. 📜 EU publishes regulation governing use of AI in medical devices and IVDs 📅 Upcoming RQM panel on 8 August: Advancing Health Equity with IVDs & Medical Devices ▶ Recording is available for RQM panel and Q&A: Beyond EtO: New EPA Regulations and Sterilization Alternatives And much more! Click below to view the newsletter and stay tuned for more updates and insights each week. Subscribe now to ensure you never miss an issue! 🚀 #RQMPlus #MedTech #HealthEquity #RegulatoryAffairs #Innovation #Healthcare

Congratulations to Allison Komiyama, PhD, RAC-US, FRAPS on Becoming a 2024 RAPS Fellow! 🌟 We are thrilled to share that Regulatory Affairs Professionals Society (RAPS) has named Allison Komiyama as one of the six exceptional regulatory professionals inducted into the prestigious RAPS Fellows Program this year. This honorary recognition is a testament to Allison's sustained leadership contributions to her organization RQM , RAPS, and the regulatory profession. Allison has been actively involved in hundreds of pre-submissions and premarket submissions for a wide array of medical device companies. In 2014, she founded AcKnowledge Regulatory Strategies, which was acquired by RQM in 2021. At RQM , she and her team continue to support small to large medical device companies throughout the entire product lifecycle, focusing on digital therapeutics, monitoring devices, smart orthopedic devices, wearable technology, pediatric devices, and neurostimulators with unique indications. Beyond her impressive professional achievements, Allison frequently presents at conferences, advises numerous technology incubators, and teaches regulatory submissions at UC San Diego Division of Extended Studies and SDSU Global Campus. Allison joins Amie Smirthwaite, PhD, FRAPS as another distinguished RAPS Fellow at RQM ! Their expertise and dedication are invaluable to our team and the regulatory community. Congratulations, Allison, on this well-deserved honor! 🎉 Learn more about the 2024 RAPS Fellows here 👉 https://lnkd.in/eNvqeAXK #RAPS #RegulatoryExcellence #Leadership #RQMPlus #RAPSFellows #MedicalDevices #RegulatoryProfessionals

🌐 𝐇𝐨𝐰 𝐃𝐢𝐆𝐀 𝐢𝐬 𝐌𝐚𝐤𝐢𝐧𝐠 𝐖𝐚𝐯𝐞𝐬 𝐢𝐧 𝐭𝐡𝐞 𝐔𝐒! 🌐 Our white paper, "The German DiGA Idea," not only explores the origins and success of DiGA in Europe but also delves into its growing impact in the US. Clinical data generated in the US can now meet the requirements to be listed in the DiGA registry, allowing digital health applications to be prescribed by physicians and psychotherapists. 𝐃𝐢𝐬𝐜𝐨𝐯𝐞𝐫: ✔️ The regulatory complexities and how CROs provide essential support ✔️ DiGA’s role in bridging regional disparities in health care provision ✔️ Practical examples of successful DiGA implementations Don't miss this opportunity to stay ahead in the evolving field of digital health, brought to you by Dr Dr Cordula Stover from RQM Clinical Trial Services Europe. 📥 𝐃𝐨𝐰𝐧𝐥𝐨𝐚𝐝 𝐭𝐡𝐞 𝐰𝐡𝐢𝐭𝐞 𝐩𝐚𝐩𝐞𝐫 𝐭𝐨𝐝𝐚𝐲: https://lnkd.in/gfpzV7-4 #RQMplus #DigitalHealth #HealthCareInnovation #DiGA #MedicalDevices #eHealth #mHealth

Senior Consultant Pamela Stogsdill said it better than we ever could. 😊 Happy Friday, everyone.

We bring as much 𝗽𝗿𝗮𝗰𝘁𝗶𝗰𝗮𝗹 𝗴𝘂𝗶𝗱𝗮𝗻𝗰𝗲 as we can to our RQM Live! panel discussions and today's session regarding the new US Environmental Protection Agency (EPA) rule on ethylene oxide (EtO) was no exception. Thanks to those who joined live! Your participation and questions were outstanding and help make these free events more valuable to everyone. 💬 "𝘌𝘹𝘤𝘦𝘭𝘭𝘦𝘯𝘵 𝘱𝘳𝘦𝘴𝘦𝘯𝘵𝘢𝘵𝘪𝘰𝘯 𝘢𝘯𝘥 𝘨𝘳𝘦𝘢𝘵 𝘘&𝘈 𝘱𝘰𝘳𝘵𝘪𝘰𝘯 𝘰𝘯 𝘌𝘵𝘖. 𝘈𝘯𝘥 𝘨𝘳𝘦𝘢𝘵 𝘵𝘢𝘬𝘦𝘢𝘸𝘢𝘺𝘴 𝘵𝘰 𝘵𝘢𝘬𝘦 𝘢𝘤𝘵𝘪𝘰𝘯 𝘰𝘯." 💬 "𝘛𝘩𝘦 𝘱𝘳𝘦𝘴𝘦𝘯𝘵𝘢𝘵𝘪𝘰𝘯 𝘴𝘵𝘶𝘤𝘬 𝘵𝘰 𝘬𝘦𝘺 𝘱𝘰𝘪𝘯𝘵𝘴 𝘳𝘢𝘵𝘩𝘦𝘳 𝘵𝘩𝘢𝘯 𝘵𝘰𝘰 𝘮𝘢𝘯𝘺 𝘱𝘰𝘪𝘯𝘵𝘴 𝘵𝘩𝘢𝘵 𝘸𝘰𝘶𝘭𝘥 𝘭𝘦𝘢𝘥 𝘵𝘰 𝘥𝘪𝘭𝘶𝘵𝘪𝘰𝘯 𝘰𝘧 𝘢𝘣𝘴𝘰𝘳𝘣𝘪𝘯𝘨 𝘱𝘦𝘳𝘵𝘪𝘯𝘦𝘯𝘵 𝘪𝘯𝘧𝘰𝘳𝘮𝘢𝘵𝘪𝘰𝘯." Also, shout out to RQM Senior Consultant Jessica Dreyer (speaking in clip), Senior Manager Greg Murdock, and VP, Technical Jonathan Gimbel for lending their time and expertise. 📥 Presentation and recording now available on demand 🔗 in comments

While she has moved towards retirement since recording this video with Jaishankar Kutty, Ph.D., Nancy Morrison, RAC talks about the regulatory landmines around 𝗰𝗼𝗺𝗯𝗶𝗻𝗮𝘁𝗶𝗼𝗻 𝗽𝗿𝗼𝗱𝘂𝗰𝘁𝘀 in the newest video in our clinical trials series. 𝗪𝗮𝘁𝗰𝗵 𝗳𝗼𝗿 𝗶𝗻𝘀𝗶𝗴𝗵𝘁𝘀 𝗼𝗻: ◽ Determining the regulatory pathway for your combination product ◾ Addressing regulators' primary concerns in submissions ◽ Overcoming clinical trial challenges unique to combination products ◾ Key learnings from real-world cases Whether developing drug-device combinations, drug-eluting implants, or other innovative combination products, this video offers guidance to help avoid costly delays and regulatory pitfalls. If you're interested in RQM helping you strategically approach combination product development and set your product up for regulatory success, let us know. 📞 #MedTech #RegulatoryAffairs #ClinicalTrials #CombinationProducts

Your curated source of weekly MedTech news has arrived. 🛬 Highlights from this week's 𝗥𝗤𝗠 𝗪𝗲𝗲𝗸𝗹𝘆 𝗪𝗮𝘁𝗰𝗵: ➕ Major updates from us, including a new white paper, two upcoming online events (one this Thursday), and new content related to clinical trials and our CAPA facilitation team 📊 EU publishes Regulation 2024/1860, extending IVDR transition timelines and introducing new supply interruption notification requirements 🤖 EU AI Act (Regulation 2024/1689) officially published, laying down harmonized rules on artificial intelligence 🩺 World Health Organization launches MeDevIS, a global open-access platform for medical device information We hope this snapshot of our regulatory intelligence keeps you informed and ahead of the curve. Read the full newsletter below. #MedicalDevices #IVD #RegulatoryAffairs #Healthcare #MedTech

💬 "𝐒𝐨𝐟𝐭 𝐬𝐤𝐢𝐥𝐥𝐬 𝐚𝐧𝐝 𝐝𝐢𝐯𝐞𝐫𝐬𝐞 𝐞𝐱𝐩𝐞𝐫𝐢𝐞𝐧𝐜𝐞 𝐦𝐚𝐭𝐭𝐞𝐫." We've highlighted members of our CAPA facilitation team over the past two weeks and the final feature is Consultant Joseph Commane. Joe brings a wealth of experience to our clients and delivers measurable success (see page 4). His expertise in regulatory compliance and quality improvement has been crucial to completing complex projects under tight deadlines... 𝗮 𝘁𝗵𝗲𝗺𝗲 𝗳𝗼𝗿 𝘁𝗵𝗶𝘀 𝘁𝗲𝗮𝗺. 💪 ➡️ Swipe to discover more about Joe 𝘈𝘵 𝘙𝘘𝘔 , 𝘸𝘦'𝘳𝘦 𝘱𝘳𝘰𝘶𝘥 𝘰𝘧 𝘦𝘹𝘱𝘦𝘳𝘵𝘴 𝘭𝘪𝘬𝘦 𝘑𝘰𝘦 𝘸𝘩𝘰 𝘦𝘮𝘣𝘰𝘥𝘺 𝘰𝘶𝘳 𝘤𝘭𝘪𝘦𝘯𝘵 𝘤𝘰𝘮𝘮𝘪𝘵𝘮𝘦𝘯𝘵. 𝘈𝘯𝘰𝘵𝘩𝘦𝘳 𝘵𝘩𝘦𝘮𝘦: 𝙏𝙝𝙚𝙞𝙧 𝙨𝙪𝙘𝙘𝙚𝙨𝙨 𝙞𝙨 𝙤𝙪𝙧 𝙨𝙪𝙘𝙘𝙚𝙨𝙨. #MedTech #CAPA #RegulatoryCompliance #QualityImprovement

We’re big fans of templates, so we'll just leave this here... 🌿 #RegulatoryCompliance #MedTech