RQM

📖 𝗡𝗘𝗪 𝗧𝗘𝗖𝗛𝗡𝗜𝗖𝗔𝗟 𝗕𝗥𝗜𝗘𝗙 — Uncover how U.S. and EU regulations shape the design, development, and approval process for 𝗣𝗼𝗶𝗻𝘁 𝗼𝗳 𝗖𝗮𝗿𝗲 𝗧𝗲𝘀𝘁𝘀 (POCT), plus actionable steps to streamline global market access. Written by Margot Borgel, Ph.D., Director of IVD Global Regulatory Affairs, this brief delivers valuable insights into: – Regulatory pathways – Clinical studies – Usability testing 🔗 https://lnkd.in/eUeSxbn9 #MedTech #IVDR #IVDRegulations #PointofCare

𝗧𝗵𝗶𝗻𝗸 𝘆𝗼𝘂’𝗿𝗲 𝘂𝗽 𝗳𝗼𝗿 𝘁𝗵𝗲 𝗲𝗾𝘂𝗶𝘃𝗮𝗹𝗲𝗻𝗰𝗲 𝗰𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲? Here's the first of three polls we have for you, but first... a quick intro. 🔍📘✍️ • • • • • • • • • • • • • • It's been over four years since the MDCG published their guidance on the use of equivalence for clinical evaluations (under the EU MDR 2017/745) in the form of MDCG 2020-5 and now we're approaching the 1st birthday of MDCG 2023-7. The latter of those gave us clarification (or correction of previous interpretations) of Article 61 of the MDR that made the prospect of using the equivalence pathway within the clinical evaluation more viable than it was. Despite that, we are still seeing differing opinions and interpretations of the requirements relating to the use of equivalence that don’t align with the intent or legal requirements of MDR Article 61. Therefore, we have 𝟯 𝗽𝗼𝗹𝗹 𝗾𝘂𝗲𝘀𝘁𝗶𝗼𝗻𝘀 that we'll ask over the course of the next few weeks to gauge industry awareness of equivalence in the EU. • • • • • • • • • • • • • • 𝗙𝗼𝗿 𝗼𝘂𝗿 𝗳𝗶𝗿𝘀𝘁 𝗽𝗼𝗹𝗹 𝗾𝘂𝗲𝘀𝘁𝗶𝗼𝗻, we're looking at 𝗪𝗛𝗘𝗡 you can use equivalence. 💭 𝗪𝗵𝗮𝘁 𝗱𝗼 𝘆𝗼𝘂 𝘁𝗵𝗶𝗻𝗸? 𝗧𝗿𝘂𝗲 𝗼𝗿 𝗳𝗮𝗹𝘀𝗲? 🤔 #MedicalDevices #MDR #MedTech #ClinicalEvaluation #RegulatoryAffairs

🔊 𝙏𝙝𝙞𝙨 𝙁𝙧𝙞𝙙𝙖𝙮, join Tom Patten of GMED and two other notified body representatives for 𝗦𝘁𝗿𝘂𝗰𝘁𝘂𝗿𝗲𝗱 𝗗𝗶𝗮𝗹𝗼𝗴𝘂𝗲: 𝗛𝗼𝘄 𝘁𝗼 𝗘𝗻𝗴𝗮𝗴𝗲 𝘄𝗶𝘁𝗵 𝗡𝗼𝘁𝗶𝗳𝗶𝗲𝗱 𝗕𝗼𝗱𝗶𝗲𝘀. Friday's panel is a unique opportunity to hear directly from three notified body leaders with hands-on experience in a single event. Did we mention the event is free? (as always!) 𝗔𝘁𝘁𝗲𝗻𝗱 𝘁𝗼 𝗹𝗲𝗮𝗿𝗻: ━ Effective submission strategies and regulatory pathways ━ How to engage notified bodies for faster, successful approvals ━ Staying ahead of regulatory changes in a fast-paced industry There’s still time to register! Secure your spot and join us LIVE ⬇️ 📅 Date: Friday, October 4 ⏰ Time: 9am ET / 3pm CEST 🎟️ Join here: https://lnkd.in/eZxKTBkb #MedTech #IVDR #RegulatoryCompliance #GMED #RQMPlus #IVDs #MDR #MedicalDevices

🚨 Watch our newest video to learn best practices for 𝗮𝗱𝘃𝗲𝗿𝘀𝗲 𝗲𝘃𝗲𝗻𝘁 𝗿𝗲𝗽𝗼𝗿𝘁𝗶𝗻𝗴 𝗶𝗻 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹𝘀. Manager of Safety Management Melanie Miller reveals: 📊 AE definitions for medical devices vs. drugs 🌍 Global reporting requirements and timelines 📋 Minimum data set for reportable AEs 🔬 Reporting differences across study types Elevate your clinical trial expertise with RQM (this is the 21st video in our clinical trials-specific video series this year) and ensure regulatory compliance. #ClinicalTrials #AdverseEvents #RegulatoryAffairs #MedTech

🔥 Hot off the press → this week's 𝗥𝗤𝗠 𝗪𝗲𝗲𝗸𝗹𝘆 𝗪𝗮𝘁𝗰𝗵 is here. At a glance... 🎙️ THIS FRIDAY: Live! panel with BSI, TÜV SÜD, and GMED on structured dialogue (Oct 4, 9am ET / 3pm CEST) 📺 Expanded Clinical Trial Video Series - now covering safety management 🏥 Join us at The MedTech Conference Powered by AdvaMed in Toronto, Oct 15-17 (Booth 631) 📋 MHRA update: Pre-market SI consultation & AI Airlock pilot open 📘 MDCG 2021-4 on IVDR class D transitional provisions updated 🔬 FDA releases final guidance on Safety and Performance Based Pathway Plus: Many more global regulatory updates worth a browse! Stay ahead in #MedTech and check out the full newsletter now. #RegulatoryAffairs #RegulatoryIntelligence #MedicalDevices #IVDs #HealthcareInnovation

3️⃣ 𝗧𝗿𝗶𝗽𝗹𝗲 𝘁𝗵𝗲 𝗘𝘅𝗽𝗲𝗿𝘁𝗶𝘀𝗲 In what might be our most exciting online event of the year, 𝘁𝗵𝗿𝗲𝗲 𝗻𝗼𝘁𝗶𝗳𝗶𝗲𝗱 𝗯𝗼𝗱𝘆 𝗿𝗲𝗽𝗿𝗲𝘀𝗲𝗻𝘁𝗮𝘁𝗶𝘃𝗲𝘀 join RQM Live! 𝘁𝗵𝗶𝘀 𝗙𝗿𝗶𝗱𝗮𝘆. Attendees will learn how to engage in structured dialogue 𝘥𝘪𝘳𝘦𝘤𝘵𝘭𝘺 from BSI, TÜV SÜD, and GMED. 𝗧𝗼𝗽𝗶𝗰𝘀 𝗶𝗻𝗰𝗹𝘂𝗱𝗲: ➕ Effective strategies for engaging in structured dialogues ➕ Managing device classifications, submission processes, and project timelines ➕ How to navigate changes in notified bodies and maintain compliance ➕ Best practices for developing regulatory plans in new technology areas 𝗧𝗵𝗲 𝗽𝗮𝗻𝗲𝗹𝗶𝘀𝘁𝘀: ➖ Alex Laan, Head of the IVD Notified Body, BSI ➖ Dr. Andreas Stange, Senior VP MHS Regulatory & Quality, TÜV SÜD ➖ Tom Patten, IVDR/IVD International Manager, GMED ➖ Jaishankar Kutty, Ph.D., VP of Global Regulatory Affairs, RQM (moderator) 𝗦𝗲𝗰𝘂𝗿𝗲 𝘆𝗼𝘂𝗿 𝘀𝗽𝗼𝘁 𝗻𝗼𝘄! https://lnkd.in/eZxKTBkb #MedTech #MedicalDevices #EUMDDR #VDR

We heard it's #InternationalPodcastDay, so here's where to follow the RQM Device Advice podcast: 🍎 Apple: https://lnkd.in/e_z6X64F 🎶 Spotify: https://lnkd.in/e_pvMbZp If you use a different platform, just search for RQM and you may find us! We appreciate you listening. 🙏 #MedTech #MedicalDevices #IVDs

👨💼 Head of IVD Notified Body at BSI, Alex Laan, is one of three notified body representatives joining our RQM Live! panel this Friday. With Alex's 𝘦𝘹𝘵𝘦𝘯𝘴𝘪𝘷𝘦 experience accessing regulatory compliance, this session is a must-attend for any MedTech manufacturer navigating IVDR compliance (and MDR, too). 𝗪𝗵𝗮𝘁 𝘁𝗼 𝗲𝘅𝗽𝗲𝗰𝘁 👇 ━ 𝗗𝗶𝗿𝗲𝗰𝘁 𝗶𝗻𝘀𝗶𝗴𝗵𝘁𝘀 on how to engage effectively with notified bodies ━ 𝗕𝗲𝘀𝘁 𝗽𝗿𝗮𝗰𝘁𝗶𝗰𝗲𝘀 for accelerating your regulatory pathways ━ 𝗖𝗿𝗶𝘁𝗶𝗰𝗮𝗹 𝘂𝗽𝗱𝗮𝘁𝗲𝘀 on navigating complex regulations 𝗗𝗲𝘁𝗮𝗶𝗹𝘀 ⬇️ 📅 Date: Friday, October 4 ⏰ Time: 9am ET / 3pm CEST 🎟️ Register now: https://lnkd.in/eZxKTBkb #MedTech #IVDR #RegulatoryAffairs #BSI #IVDs #MDR #MedicalDevices

RQM Senior Manager of Technical, Bethany Knorr Chung, PhD, RAC, will be one of just five speakers at 3Aware's next intentionally tailored event in their RWE-Driven MedTech Symposium series: 𝗔𝗰𝗵𝗶𝗲𝘃𝗶𝗻𝗴 𝗥𝗲𝗹𝗶𝗮𝗯𝗶𝗹𝗶𝘁𝘆 & 𝗥𝗲𝗹𝗲𝘃𝗮𝗻𝗰𝗲 𝘄𝗶𝘁𝗵 𝗥𝗲𝗮𝗹-𝗪𝗼𝗿𝗹𝗱 𝗗𝗮𝘁𝗮. She'll cover using RWE for entering new markets: > Identifying the Need for RWE > Determining Appropriate Sources > Understanding Standard of Care > Assessing Quality, Cost & Timing More information below 👇 #MedTech #RWE #RealWorldData #MedicalDevices