RQM+

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

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🔮 What dream projects do RQM+ consultants have? Our CAPA facilitation experts return to share their 𝗶𝗱𝗲𝗮𝗹 𝗽𝗿𝗼𝗷𝗲𝗰𝘁𝘀 𝗮𝗻𝗱 𝗽𝗲𝗿𝘀𝗼𝗻𝗮𝗹 𝗽𝗮𝘀𝘀𝗶𝗼𝗻𝘀 in this short clip from their roundtable discussion with Scott Edwards, Managing Director. 🌟💭 Consultants' dream projects 📈❤️ How these align with industry trends and personal passions We hope you enjoy learning about the diverse interests of our team - from 𝘀𝗼𝗹𝘃𝗶𝗻𝗴 𝗯𝗶𝗴 𝗽𝗿𝗼𝗯𝗹𝗲𝗺𝘀 to 𝗱𝗲𝘃𝗲𝗹𝗼𝗽𝗶𝗻𝗴 𝗻𝗲𝘅𝘁-𝗴𝗲𝗻 𝗱𝗶𝗮𝗯𝗲𝘁𝗲𝘀 𝗺𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗱𝗲𝘃𝗶𝗰𝗲𝘀. At RQM+, the success of our clients is driven by the expertise and passion of our people. #MedTech #MedicalDevices #RegulatoryAffairs

On Thursday, 8 August, RQM+ welcomes Michelle Tarver, MD, PhD, Deputy Center Director for Transformation, FDA, CDRH, to a panel and interactive Q&A session aimed at increasing awareness and understanding of equity in the medical device and IVD space. 🏛️ 𝗢𝗯𝗷𝗲𝗰𝘁𝗶𝘃𝗲𝘀: – Regulatory expectations – Healthcare at Home initiatives – Industry perspectives, action plans, and diversity strategies 📅 Thursday, August 8, 2024 💡 Interactive Q&A session included Help shape a more equitable future in #MedTech by joining us. Learn more and find the URL to register at the LinkedIn event below. #HealthEquity #MedicalDevices #IVDs #RegulatoryAffairs #Healthcare

In this clip from a longer conversation (full version on our podcast and YouTube, linked in comments), Senior Principal Consultant Chad Quistad talks with Jaishankar Kutty, Ph.D. and breaks down the essentials behind 𝗰𝗼𝗺𝗯𝗶𝗻𝗮𝘁𝗶𝗼𝗻 𝗱𝗲𝘃𝗶𝗰𝗲 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹𝘀. ➡️ What qualifies as a combination device ➡️ Key regulatory pathways in the US and EU ➡️ Common development challenges 𝘋𝘪𝘥 𝘺𝘰𝘶 𝘬𝘯𝘰𝘸 𝘵𝘩𝘦 𝘳𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘺 𝘢𝘱𝘱𝘳𝘰𝘢𝘤𝘩 𝘥𝘪𝘧𝘧𝘦𝘳𝘴 𝘣𝘢𝘴𝘦𝘥 𝘰𝘯 𝘵𝘩𝘦 𝘥𝘦𝘷𝘪𝘤𝘦'𝘴 𝘱𝘳𝘪𝘮𝘢𝘳𝘺 𝘮𝘰𝘥𝘦 𝘰𝘧 𝘢𝘤𝘵𝘪𝘰𝘯? 💡 Below is every video we've posted as part of our clinical trial series thus far: 1. Introducing Our Educational Series on Clinical Trials 2. Strategy for First-in-Human Studies (1/2) 3. Strategy for First-in-Human Studies (2/2) 4. Tactics for First-in-Human Studies 5. Strategy for Global Pivotal Studies 6. Tactics for Global Pivotal Studies 7. Would you like to get reimbursed? 8. Key Aspects of Medical Device Trial Design (1/2) 9. Key Aspects of Medical Device Trial Design (2/2) 𝟭𝟬. 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝘆 𝗮𝗻𝗱 𝗧𝗮𝗰𝘁𝗶𝗰𝘀 𝗳𝗼𝗿 𝗖𝗼𝗺𝗯𝗶𝗻𝗮𝘁𝗶𝗼𝗻 𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀 #MedTech #ClinicalTrials #RegulatoryAffairs #CombinationDevices

📘 The US Environmental Protection Agency (EPA)'s recent ethylene oxide (EtO) regulations aren't just changing the game—they're rewriting the rulebook. In just 𝟳 𝗱𝗮𝘆𝘀, we hope you'll join us for... 💉 𝗕𝗲𝘆𝗼𝗻𝗱 𝗘𝘁𝗢: 𝗡𝗲𝘄 𝗘𝗣𝗔 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻𝘀 𝗮𝗻𝗱 𝗦𝘁𝗲𝗿𝗶𝗹𝗶𝘇𝗮𝘁𝗶𝗼𝗻 𝗔𝗹𝘁𝗲𝗿𝗻𝗮𝘁𝗶𝘃𝗲𝘀 📆 18 July 2024 | 11am ET / 5pm CEST Our expert panel will cover: – Impact of new EPA rules on sterilization facilities and manufacturers – Compliance strategies and emission reduction techniques – Alternative sterilization methods: VHP, radiation, and more – Quality and regulatory support insights – Industry perspectives and adaptation strategies *𝘞𝘦'𝘭𝘭 𝘣𝘦 𝘴𝘵𝘢𝘳𝘵𝘪𝘯𝘨 𝘵𝘩𝘦 𝘱𝘢𝘯𝘦𝘭 𝘰𝘧𝘧 𝘸𝘪𝘵𝘩 𝘴𝘰𝘮𝘦 𝘱𝘳𝘦𝘴𝘦𝘯𝘵𝘢𝘵𝘪𝘰𝘯 𝘴𝘭𝘪𝘥𝘦𝘴 𝘢𝘯𝘥 𝘸𝘪𝘭𝘭 𝘣𝘦 𝘴𝘩𝘢𝘳𝘪𝘯𝘨 𝘵𝘩𝘦 𝘴𝘭𝘪𝘥𝘦𝘴 𝘸𝘪𝘵𝘩 𝘢𝘭𝘭 𝘳𝘦𝘨𝘪𝘴𝘵𝘳𝘢𝘯𝘵𝘴.* Featuring RQM+ experts: – Jessica Dreyer, Senior Consultant – Greg Murdock, Senior Manager – Jonathan Gimbel, Ph.D., VP, Technical (moderator) Perfect for regulatory affairs professionals, quality engineers, and medical device manufacturers. Link to register in the comments 👇 #MedicalDevices #Sterilization #RegulatoryCompliance #EPARegulations