RQM

🆕 It's quality over quantity this week. While last week's US holiday has resulted in a lighter newsletter than usual, this week's 𝗥𝗤𝗠 𝗪𝗲𝗲𝗸𝗹𝘆 𝗪𝗮𝘁𝗰𝗵 still delivers key MedTech insights and developments. Highlights... 🔄 MDCG 2021-5 has been updated to revision 1, with clarifications on EU harmonized standards 📊 The expansion of FDA's Total Product Life Cycle (TPLC) Advisory Program (TAP) to include new clinical areas 💼 Over 100 industry associations, including MedTech Europe and COCIR, called for an increased budget in FP10 (EU Framework Programme) to support EU competitiveness 📜 New EU Regulation (EU) 2024/1781 establishing a framework for ecodesign requirements for sustainable products, entering into force on July 18, 2024 📅 Upcoming RQM panel and Q&A on 18 July: Beyond EtO: New EPA Regulations and Sterilization Alternatives Access the entire newsletter below for a thorough industry update. #MedTech #MedicalDevices #RegulatoryCompliance #ClinicalTrials hashtag #RegulatoryIntelligence

💡🏥 𝗨𝗻𝘃𝗲𝗶𝗹𝗶𝗻𝗴 𝘁𝗵𝗲 𝗦𝗲𝗰𝗿𝗲𝘁𝘀 𝗼𝗳 𝗦𝘂𝗰𝗰𝗲𝘀𝘀𝗳𝘂𝗹 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀 Part 2 of key aspects of device trial design covers: – Overcoming key barriers in trial design – Balancing statistical significance with clinical relevance – Strategies for faster enrollment and reduced dropouts Optimize your next clinical trial with valuable insights from Cari Kniola, Guido Rieger, Rolf Hövelmann, and Jaishankar Kutty, Ph.D.. 🔑 Key takeaway? 𝗘𝘅𝗽𝗲𝗿𝗶𝗲𝗻𝗰𝗲 𝗺𝗮𝘁𝘁𝗲𝗿𝘀. Learn how RQM leverages cross-functional expertise to design trials that deliver meaningful results. #MedTech #ClinicalTrials #RegulatoryAffairs #MedicalDevices

Meet Craig McIntire, Senior Consultant at RQM . 8 years in MedTech top-tier quality consulting = 𝗺𝗲𝗮𝘀𝘂𝗿𝗮𝗯𝗹𝗲 𝗰𝗹𝗶𝗲𝗻𝘁 𝘀𝘂𝗰𝗰𝗲𝘀𝘀. ➡️ Swipe to see how Craig optimized client processes and what he wished he knew earlier in his career! (hint: 👂) #MedTech #CAPA #RegulatoryCompliance #QualityImprovement #QMS

The EPA has mandated a 90% reduction in EtO emissions from sterilization facilities within 2-3 years. This affects 50% of sterile medical devices sold in the U.S. - over 20 billion devices annually. 𝗪𝗵𝗮𝘁 𝗱𝗼𝗲𝘀 𝘁𝗵𝗶𝘀 𝗺𝗲𝗮𝗻 𝗳𝗼𝗿 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲 𝗺𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗲𝗿𝘀? – Potential disruptions in sterilization services – Need for process revalidation – Exploration of alternative sterilization methods Our latest technical brief by Jonathan Gimbel breaks down the impact and offers actionable strategies: https://lnkd.in/emY8KVUi After reading the brief, want to engage directly with experts? Join our panel on July 18th for 𝗕𝗲𝘆𝗼𝗻𝗱 𝗘𝘁𝗢: 𝗡𝗲𝘄 𝗘𝗣𝗔 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻𝘀 𝗮𝗻𝗱 𝗦𝘁𝗲𝗿𝗶𝗹𝗶𝘇𝗮𝘁𝗶𝗼𝗻 𝗔𝗹𝘁𝗲𝗿𝗻𝗮𝘁𝗶𝘃𝗲𝘀. Register here: https://lnkd.in/eEiV4PYn #MedicalDevices #Sterilization #RegulatoryCompliance #EPA

🤔 Struggling with patient recruitment for your medical device clinical studies? [𝗡𝗼𝘄 𝗢𝗻 𝗗𝗲𝗺𝗮𝗻𝗱] Modernizing MedTech Research via Hybrid Study Approaches to Enhance Your Patient Recruitment Learn how hybrid approaches can: – Expand your recruitment reach beyond geographical limitations – Boost patient engagement and retention rates – Save time and resources on data collection – Ultimately accelerate your product's path to market Watch THREAD's John Reites and RQM 's David Novotny discuss practical strategies to make your studies more patient-centric and efficient. Transform your research process and access the webinar: https://lnkd.in/e87Xi5Xu #MedTechInnovation #ClinicalTrialEfficiency #PatientCentricResearch #MedTech #ClinicalTrials #CRO

Did you know that upon request, we offer a 𝗖𝗲𝗿𝘁𝗶𝗳𝗶𝗰𝗮𝘁𝗲 𝗼𝗳 𝗣𝗮𝗿𝘁𝗶𝗰𝗶𝗽𝗮𝘁𝗶𝗼𝗻 to anyone who attends our online events live? This certificate is a great way to showcase your commitment to continuous learning and can be shared with your manager to highlight professional development efforts. To request your certificate, simply reach out to our team after attending any live event and we'll send you yours. The next opportunity is on Thursday, 18 July, for our panel and Q&A session: 𝗕𝗲𝘆𝗼𝗻𝗱 𝗘𝘁𝗢: 𝗡𝗲𝘄 𝗘𝗣𝗔 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻𝘀 𝗮𝗻𝗱 𝗦𝘁𝗲𝗿𝗶𝗹𝗶𝘇𝗮𝘁𝗶𝗼𝗻 𝗔𝗹𝘁𝗲𝗿𝗻𝗮𝘁𝗶𝘃𝗲𝘀. 🗣️ https://lnkd.in/eEiV4PYn We are proud to offer these and believe in recognizing the dedication and growth of anyone who joins our educational events! #MedTech #MedicalDevices #ContinuingEducation

A few highlights from this week's new edition of our LinkedIn newsletter, the 𝗥𝗤𝗠 𝗪𝗲𝗲𝗸𝗹𝘆 𝗪𝗮𝘁𝗰𝗵: ✅ 𝗥𝗤𝗠 𝗥𝗲𝗰𝗮𝗽 – New technical briefs on 𝗮𝗻𝗮𝗹𝘆𝘁𝗶𝗰𝗮𝗹 𝘁𝗲𝘀𝘁𝗶𝗻𝗴 and 𝗰𝗵𝗲𝗺𝗶𝗰𝗮𝗹 𝗰𝗵𝗮𝗿𝗮𝗰𝘁𝗲𝗿𝗶𝘇𝗮𝘁𝗶𝗼𝗻 – 18 July panel discussion around the 𝗳𝗶𝗻𝗮𝗹𝗶𝘇𝗲𝗱 𝗘𝗣𝗔 𝗿𝘂𝗹𝗲 𝗼𝗻 𝗘𝘁𝗢 – Summary of our 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹 𝘃𝗶𝗱𝗲𝗼 𝘀𝗲𝗿𝗶𝗲𝘀 on LinkedIn, Apple, Spotify, and YouTube 🌍 𝗜𝗻𝘁𝗲𝗹𝗹𝗶𝗴𝗲𝗻𝗰𝗲 𝗨𝗽𝗱𝗮𝘁𝗲𝘀 – MDCG's new guidance on orphan medical devices – FDA's latest guidance on Lab Developed Tests and diversity in clinical studies (𝘩𝘢𝘷𝘦 𝘺𝘰𝘶 𝘴𝘦𝘦𝘯 𝘰𝘶𝘳 𝘳𝘦𝘤𝘦𝘯𝘵 𝘓𝘋𝘛 𝘸𝘦𝘣𝘪𝘯𝘢𝘳? - check the comments) 👀 𝗜𝗻 𝘁𝗵𝗲 𝗡𝗲𝘄𝘀 – Philips BiPAP recall linked to 65 deaths and 952 injuries – Abbott's HeartMate LVAS System Monitor correction Keep up with industry news and trends by viewing the full edition below. #MedTech #MedicalDevices #RegulatoryCompliance #ClinicalTrials #HealthcareInnovation #RegulatoryIntelligence #EtO

✏️ 𝗞𝗲𝘆 𝗔𝘀𝗽𝗲𝗰𝘁𝘀 𝗼𝗳 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹 𝗗𝗲𝘀𝗶𝗴𝗻 (𝟭/𝟮) Cari Kniola, Guido Rieger, and Jaishankar Kutty, Ph.D. return for our educational clinical trial series, this time joined by Senior Manager of Biostatistics, Rolf Hövelmann. This video covers... 𝗖𝗿𝘂𝗰𝗶𝗮𝗹 𝗧𝗿𝗶𝗮𝗹 𝗗𝗲𝘀𝗶𝗴𝗻 𝗙𝗮𝗰𝘁𝗼𝗿𝘀: – Addressing and mitigating confounding factors, biases, and variations – Ensuring treatment effects can be isolated 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝗰 𝗔𝗽𝗽𝗿𝗼𝗮𝗰𝗵: – The importance of considering end goals for product and study – Incorporating clinical expertise from the start 𝗦𝘁𝗮𝘁𝗶𝘀𝘁𝗶𝗰𝗮𝗹 𝗔𝗽𝗽𝗿𝗼𝗮𝗰𝗵: – Effective trial design from a biostatistics perspective – Traditional vs. adaptive trial designs 𝗥𝗲𝗮𝗹-𝗪𝗼𝗿𝗹𝗱 𝗜𝗻𝘀𝗶𝗴𝗵𝘁𝘀: – Balancing regulatory, reimbursement, and practical clinical needs – Ensuring feasibility and practicality in trial execution Look for the second video about trial design next week! Reminder that you can find all of our clinical trial videos outside of LinkedIn, too. 👇 🎧 The RQM Device Advice podcast: Apple: https://lnkd.in/e_z6X64F Spotify: https://lnkd.in/d4U5Za3 📺 The RQM YouTube channel: https://lnkd.in/eVSp6tAB 📧 For support with clinical trials, you can contact us directly here: https://lnkd.in/dwm9SzQ **𝘛𝘩𝘪𝘴 𝘷𝘪𝘥𝘦𝘰 𝘪𝘴 𝘱𝘢𝘳𝘵 𝘰𝘧 𝘰𝘶𝘳 𝘦𝘥𝘶𝘤𝘢𝘵𝘪𝘰𝘯𝘢𝘭 𝘷𝘪𝘥𝘦𝘰 𝘴𝘦𝘳𝘪𝘦𝘴 𝘰𝘯 𝘤𝘭𝘪𝘯𝘪𝘤𝘢𝘭 𝘵𝘳𝘪𝘢𝘭𝘴. 𝘊𝘭𝘪𝘱𝘴 𝘸𝘪𝘭𝘭 𝘤𝘰𝘷𝘦𝘳 𝘵𝘩𝘳𝘦𝘦 𝘬𝘦𝘺 𝘢𝘳𝘦𝘢𝘴: 𝘤𝘭𝘪𝘯𝘪𝘤𝘢𝘭 𝘵𝘳𝘪𝘢𝘭 𝘴𝘵𝘳𝘢𝘵𝘦𝘨𝘺, 𝘤𝘭𝘪𝘯𝘪𝘤𝘢𝘭 𝘵𝘳𝘪𝘢𝘭 𝘦𝘹𝘦𝘤𝘶𝘵𝘪𝘰𝘯, 𝘢𝘯𝘥 𝘳𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘺 𝘦𝘹𝘱𝘦𝘳𝘵𝘪𝘴𝘦 𝘪𝘯 𝘤𝘭𝘪𝘯𝘪𝘤𝘢𝘭 𝘵𝘳𝘪𝘢𝘭𝘴.** #MedTech #CRO #ClinicalTrials #ClinicalTrialDesign #RegulatoryAffairs

At RQM , the success of our clients is driven by the expertise and passion of our people. One of those experts is Senior Consultant, Elaine Pinto-Ruminski, MS. 🌟 Elaine is part of our 𝗖𝗔𝗣𝗔 𝗳𝗮𝗰𝗶𝗹𝗶𝘁𝗮𝘁𝗶𝗼𝗻 𝘁𝗲𝗮𝗺 and we'll be highlighting several members from this team in the coming days. The team recently – and successfully – completed a sensitive and critical project under extreme pressure from the client and the FDA. Swipe to learn more about Elaine's contributions and her role at RQM ➡️ Elaine's example is just one of many that showcase the dedication we have to our clients. 𝗧𝗵𝗲𝗶𝗿 𝘀𝘂𝗰𝗰𝗲𝘀𝘀 𝗶𝘀 𝗼𝘂𝗿 𝘀𝘂𝗰𝗰𝗲𝘀𝘀. We can't wait to highlight more team members soon – stay tuned! #MedTech #ExpertiseShowcase #CAPA #RegulatoryCompliance #QualityImprovement

We know it's late on a Friday and we'll have 𝘮𝘶𝘤𝘩 more information (including an associated technical brief 📄) next week, but we couldn't help to share our next RQM Live! panel discussion. On 𝗧𝗵𝘂𝗿𝘀𝗱𝗮𝘆, 𝟭𝟴 𝗝𝘂𝗹𝘆, Senior Consultant Jessica Dreyer and Senior Manager Greg Murdock will join moderator Jonathan Gimbel to discuss the recently finalized US Environmental Protection Agency (EPA) rule on ethylene oxide (EtO) emissions. The rule requires significant changes for sterilization facilities, potentially impacting manufacturers of sterile medical devices. 👇 Read all about the session and register at the link (also in the comments). We also hope you have a wonderful weekend!