Jordi Labs, an RQM+ Company

🌀 Rewinding to November's panel discussion on critical shifts in biological evaluation – 𝘯𝘰𝘸 𝘢𝘷𝘢𝘪𝘭𝘢𝘣𝘭𝘦 𝘰𝘯 𝘥𝘦𝘮𝘢𝘯𝘥 – Jordi Labs, an RQM+ Company Director of Biological Evaluation Taryn Meade offers a high-level overview of the looming changes to ISO 10993-1. For full details and what you can expect to get out of watching or listening to the session, follow the link in the comments. #BiologicalEvaluation #ISO10993 #MedicalDevices

📢 𝗥𝗤𝗠+ 𝗪𝗲𝗲𝗸𝗹𝘆 𝗪𝗮𝘁𝗰𝗵: 𝗙𝗶𝗻𝗮𝗹 𝟮𝟬𝟮𝟰 𝗘𝗱𝗶𝘁𝗶𝗼𝗻 We introduced our LinkedIn-exclusive newsletter in March of this year and hope you found value whenever clicking through. Today marks our final newsletter for this year. The big news last week from an RQM+ perspective was our presentation and panel discussion on cybersecurity. The slides, recording, and summary of topics discussed with timestamps are available on demand. As you'd expect this time of year, industry news is on the lighter side, but here are a few highlights (links to much more in the newsletter): 🌍 European Key Developments: 🔹 EU MDR/IVDR Q&A updated for Article 10a requirements. 🔹 European Commission opens targeted evaluation consultation on EU MDR/IVDR (closes March 21, 2025). 🔹 UK MHRA updates its Regulatory Reform Roadmap—2025 will be a busy year for MedTech in the UK! 🔎 In the News: ➡️ FDA’s first ‘Early Alert’ pilot: Fresenius infusion pump issue. ➡️ New FDA approvals: Endoquest robotic system, Artivion aortic tear implant, and AngioDynamics prostate cancer ablation. 𝗧𝗵𝗮𝗻𝗸 𝘆𝗼𝘂 𝘁𝗼 𝗮𝗹𝗹 𝘀𝘂𝗯𝘀𝗰𝗿𝗶𝗯𝗲𝗿𝘀 𝗼𝗳 𝘁𝗵𝗲 𝗥𝗤𝗠+ 𝗪𝗲𝗲𝗸𝗹𝘆 𝗪𝗮𝘁𝗰𝗵! 𝗜𝗳 𝘆𝗼𝘂'𝗿𝗲 𝗻𝗼𝘁 𝘀𝘂𝗯𝘀𝗰𝗿𝗶𝗯𝗲𝗱, 𝘄𝗲 𝘄𝗲𝗹𝗰𝗼𝗺𝗲 𝘆𝗼𝘂 𝘁𝗼 𝗳𝗼𝗿 𝟮𝟬𝟮𝟱. ✨ #MedTech #Cybersecurity #RegulatoryUpdates #MedicalDevices #RegulatoryIntelligence

𝗔𝗻 𝗢𝘃𝗲𝗿𝘃𝗶𝗲𝘄 𝗼𝗳 𝗖𝗵𝗲𝗺𝗶𝗰𝗮𝗹 𝗖𝗵𝗮𝗿𝗮𝗰𝘁𝗲𝗿𝗶𝘇𝗮𝘁𝗶𝗼𝗻 𝗼𝗳 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲𝘀 Explore the intricacies of medical device materials in this technical brief by EVP & GM of Jordi Labs, Kevin Rowland. You'll learn why why robust chemical characterization is vital for patient safety and regulatory compliance. 🧪 ISO 10993 Standards: Ensuring biocompatibility and safe use. 🔍 Extractables & Leachables: Identifying potential risks. ⚠️ Toxicological Risk Assessment: From hazard to risk characterization. 🧬 Biological Equivalence: Leveraging existing data for new devices. Navigate the complexities of chemical characterization to enhance device reliability and efficacy. Read the full technical brief to understand how RQM+ can guide you through these critical processes. 🔗 https://lnkd.in/ecEBwyew

💡 "𝘛𝘩𝘦 𝘪𝘯𝘵𝘦𝘯𝘵𝘪𝘰𝘯 𝘪𝘴 𝘯𝘰𝘵 𝘵𝘰 𝘥𝘳𝘪𝘷𝘦 𝘢 𝘸𝘩𝘰𝘭𝘦 𝘣𝘪𝘨 𝘳𝘦𝘦𝘷𝘢𝘭𝘶𝘢𝘵𝘪𝘰𝘯 𝘧𝘰𝘳 𝘦𝘷𝘦𝘳𝘺𝘵𝘩𝘪𝘯𝘨 𝘵𝘩𝘢𝘵 𝘪𝘴 𝘢𝘭𝘳𝘦𝘢𝘥𝘺 𝘢𝘱𝘱𝘳𝘰𝘷𝘦𝘥 𝘢𝘯𝘥 𝘤𝘶𝘳𝘳𝘦𝘯𝘵𝘭𝘺 𝘶𝘴𝘦𝘥." – Taryn Meade As #MedTech braces for significant updates to ISO 10993-1, concerns about the impact on existing devices are at the forefront. In yesterday's RQM+ Live! panel discussion, Jordi Labs, an RQM+ Company experts addressed many of the anxieties we've heard about from clients head-on. Dive into the full on-demand discussion to learn: ✅ The most critical changes to ISO 10993-1 and their implementation timeline ✅ How to integrate the ISO 14971 risk management framework into biological evaluation ✅ Strategic considerations for compliance during the transition 🎥 Watch on-demand: https://lnkd.in/eJrjxKND #ISO10993 #BiologicalEvaluation #RiskManagement #Toxicology

Prepare for ISO 10993-1 updates with insights from leading toxicologists. 𝗝𝗼𝗶𝗻 𝘂𝘀 𝗧𝗵𝘂𝗿𝘀𝗱𝗮𝘆 𝗳𝗼𝗿 𝗥𝗤𝗠+ 𝗟𝗶𝘃𝗲! 🎙️ Top-tier experts from Jordi Labs, an RQM+ Company (full panel listed below) will discuss the upcoming revisions to ISO 10993-1 and their implications for biological evaluation processes. 𝘐𝘧 𝘺𝘰𝘶’𝘳𝘦 𝘪𝘯 𝘳𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘺 𝘢𝘧𝘧𝘢𝘪𝘳𝘴, 𝘲𝘶𝘢𝘭𝘪𝘵𝘺 𝘮𝘢𝘯𝘢𝘨𝘦𝘮𝘦𝘯𝘵, 𝘙&𝘋, 𝘰𝘳 𝘢 𝘳𝘰𝘭𝘦 𝘪𝘯 𝘥𝘦𝘷𝘪𝘤𝘦 𝘥𝘦𝘷𝘦𝘭𝘰𝘱𝘮𝘦𝘯𝘵, 𝘵𝘩𝘪𝘴 𝘴𝘦𝘴𝘴𝘪𝘰𝘯 𝘪𝘴 𝘢 𝘧𝘪𝘵 𝘧𝘰𝘳 𝘺𝘰𝘶! Meet the panelists: Taryn Meade – Director of Biological Evaluation Stephen Bond – Senior Toxicologist Amanda DeGraw, MS, PhD, DABT – Principal Toxicologist Christine Santagate, RAC – VP of Lab Services (Moderator) Can’t make it live? No problem—register to receive the recording and a timestamped summary. Link below!   📅 Date: Thursday, 21 November 🕘 Time: 11:00am ET | 5:00pm CEST 👩💻 Secure Your Spot for the Panel > https://lnkd.in/eJrjxKND

Jordi Labs, an RQM+ Company's Taryn Meade leads an exciting and accomplished group of panelists in next week's RQM+ Live! panel discussion — 𝗖𝗿𝗶𝘁𝗶𝗰𝗮𝗹 𝗦𝗵𝗶𝗳𝘁𝘀 𝗶𝗻 𝗕𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝗮𝗹 𝗘𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝗼𝗻: Inside the New ISO 10993-1 Risk Management Framework Learn more and sign up for the event here ➡️ https://lnkd.in/eJrjxKND #BiologicalEvaluation #RegulatoryAffairs #MedTech

🔄 Major changes are coming to 𝗜𝗦𝗢 𝟭𝟬𝟵𝟵𝟯-𝟭 that will transform how MedTech manufacturers approach biological evaluation. Is your team ready? Join premier experts from Jordi Labs, an RQM+ Company for an essential conversation exploring the new ISO 10993-1 risk management framework. Attendees will leave with practical strategies to... ✓ 𝗡𝗮𝘃𝗶𝗴𝗮𝘁𝗲 𝘁𝗵𝗲 𝗶𝗻𝘁𝗲𝗴𝗿𝗮𝘁𝗶𝗼𝗻 𝗼𝗳 𝗜𝗦𝗢 𝟭𝟰𝟵𝟳𝟭 𝗽𝗿𝗶𝗻𝗰𝗶𝗽𝗹𝗲𝘀 𝗶𝗻𝘁𝗼 𝘆𝗼𝘂𝗿 𝗯𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝗮𝗹 𝗲𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝗼𝗻 𝗽𝗿𝗼𝗰𝗲𝘀𝘀 ✓ 𝗜𝗺𝗽𝗹𝗲𝗺𝗲𝗻𝘁 𝗻𝗲𝘄 𝗿𝗶𝘀𝗸 𝗲𝘀𝘁𝗶𝗺𝗮𝘁𝗶𝗼𝗻 𝗮𝗽𝗽𝗿𝗼𝗮𝗰𝗵𝗲𝘀 𝘁𝗵𝗮𝘁 𝗮𝗹𝗶𝗴𝗻 𝘄𝗶𝘁𝗵 𝗰𝗼𝗺𝗶𝗻𝗴 𝗿𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀 ✓ 𝗔𝗱𝗮𝗽𝘁 𝘆𝗼𝘂𝗿 𝗱𝗲𝘃𝗶𝗰𝗲 𝗰𝗮𝘁𝗲𝗴𝗼𝗿𝗶𝘇𝗮𝘁𝗶𝗼𝗻 𝗺𝗲𝘁𝗵𝗼𝗱𝘀 𝘁𝗼 𝗮𝗰𝗰𝗼𝘂𝗻𝘁 𝗳𝗼𝗿 𝗺𝗼𝗱𝗶𝗳𝗶𝗲𝗱 𝗯𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝗮𝗹 𝗲𝗳𝗳𝗲𝗰𝘁𝘀 ✓ 𝗠𝗮𝗶𝗻𝘁𝗮𝗶𝗻 𝗰𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 𝗱𝘂𝗿𝗶𝗻𝗴 𝘁𝗵𝗶𝘀 𝘀𝗶𝗴𝗻𝗶𝗳𝗶𝗰𝗮𝗻𝘁 𝘁𝗿𝗮𝗻𝘀𝗶𝘁𝗶𝗼𝗻 Featured experts: Taryn Meade – Director of Biological Evaluation Stephen Bond – Senior Toxicologist Amanda DeGraw, MS, PhD, DABT – Principal Toxicologist Moderated by Christine Santagate, RAC – VP of Lab Services 🗓️ November 21, 2024 ⏰ 11am ET / 5pm CEST 📝 Certificate of Participation available for live attendees Don't miss this chance to get ahead of what's being called "one of the major changes in the standard." Your proactive participation today will help ensure your submissions succeed tomorrow. ✍ https://lnkd.in/eJrjxKND #MedTech #RegulatoryCompliance #MedicalDevices #ISO10993 #BiologicalEvaluation #QualityManagement

Yesterday over at the RQM+ page, we announced a new lab-focused panel discussion – 𝗖𝗿𝗶𝘁𝗶𝗰𝗮𝗹 𝗦𝗵𝗶𝗳𝘁𝘀 𝗶𝗻 𝗕𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝗮𝗹 𝗘𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝗼𝗻: 𝗜𝗻𝘀𝗶𝗱𝗲 𝘁𝗵𝗲 𝗡𝗲𝘄 𝗜𝗦𝗢 𝟭𝟬𝟵𝟵𝟯-𝟭 𝗥𝗶𝘀𝗸 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗙𝗿𝗮𝗺𝗲𝘄𝗼𝗿𝗸. 🥼 𝗔𝘁𝘁𝗲𝗻𝗱𝗲𝗲𝘀 𝘄𝗶𝗹𝗹: ✔️ Master the new ISO 14971 framework application to biological evaluation ✔️ Understand critical updates to device categorization ✔️ Get ahead of changes before they take effect ✔️ Learn implementation strategies for maintaining compliance 𝗝𝗼𝗿𝗱𝗶 𝗟𝗮𝗯𝘀 𝗽𝗮𝗻𝗲𝗹𝗶𝘀𝘁𝘀 𝗮𝗻𝗱 𝗺𝗼𝗱𝗲𝗿𝗮𝘁𝗼𝗿: – Taryn Meade, Director of Biological Evaluation – Stephen Bond, Senior Toxicologist – Amanda DeGraw, MS, PhD, DABT, Principal Toxicologist – Christine Santagate, RAC, VP of Lab Services (Moderator) 🧪 The special event is on 𝙏𝙝𝙪𝙧𝙨𝙙𝙖𝙮, 𝙉𝙤𝙫𝙚𝙢𝙗𝙚𝙧 21𝙨𝙩 and you can sign up here: https://lnkd.in/eJrjxKND #MedTech #ISO10993 #BiologicalEvaluation #RegulatoryAffairs #MedicalDevices #QualityManagement #RiskManagement

Director of IVD Global Regulatory Affairs, Margot Borgel, Ph.D., answers seven of the biggest questions about #LDTs right now in a brand new technical brief. When will we have an answer about the lawsuit❓ What happens if ACLA/AMP win their lawsuit❓ What happens if FDA wins their lawsuit❓ What if the lawsuit isn’t resolved before May 6, 2025 or the decision is appealed❓ What about the election❓ Will we see the return of the VALID act❓ and, of course... 𝗪𝗵𝗮𝘁 𝘀𝗵𝗼𝘂𝗹𝗱 𝗹𝗮𝗯𝗼𝗿𝗮𝘁𝗼𝗿𝗶𝗲𝘀 𝗯𝗲 𝗱𝗼𝗶𝗻𝗴❓ 🔗 https://lnkd.in/eMmM8inx #MedTech #IVDs #LabTesting #Diagnostics #RegulatoryAffairs

Executive Vice President and General Manager, Kevin Rowland, will be presenting the following session at Extractables and Leachables West 2024 on Wednesday, November 13 👇 𝗖𝗿𝗶𝘁𝗶𝗰𝗮𝗹 𝗜𝘀𝘀𝘂𝗲𝘀—𝗥𝗲𝗳𝗶𝗻𝗶𝗻𝗴 𝗨𝗻𝗰𝗲𝗿𝘁𝗮𝗶𝗻𝘁𝘆 𝗙𝗮𝗰𝘁𝗼𝗿 𝗠𝗲𝘁𝗵𝗼𝗱𝗼𝗹𝗼𝗴𝘆 𝗮𝗻𝗱 𝗔𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻 It's incredibly detailed, but for those interested, we'll share the description of the session in its entirety below! If you're attending the event and this topic is relevant to you, we hope you'll connect with Kevin onsite. 𝘗𝘳𝘰𝘱𝘦𝘳 𝘮𝘢𝘯𝘢𝘨𝘦𝘮𝘦𝘯𝘵 𝘰𝘧 𝘵𝘩𝘦 𝘢𝘯𝘢𝘭𝘺𝘵𝘪𝘤𝘢𝘭 𝘶𝘯𝘤𝘦𝘳𝘵𝘢𝘪𝘯𝘵𝘺 𝘪𝘯𝘷𝘰𝘭𝘷𝘦𝘥 𝘪𝘯 𝘤𝘩𝘦𝘮𝘪𝘤𝘢𝘭 𝘤𝘩𝘢𝘳𝘢𝘤𝘵𝘦𝘳𝘪𝘻𝘢𝘵𝘪𝘰𝘯 𝘰𝘧 𝘌𝘹𝘵𝘳𝘢𝘤𝘵𝘢𝘣𝘭𝘦𝘴 𝘢𝘯𝘥 𝘓𝘦𝘢𝘤𝘩𝘢𝘣𝘭𝘦𝘴 𝘪𝘴 𝘤𝘳𝘪𝘵𝘪𝘤𝘢𝘭 𝘵𝘰 𝘦𝘯𝘴𝘶𝘳𝘦 𝘱𝘢𝘵𝘪𝘦𝘯𝘵 𝘴𝘢𝘧𝘦𝘵𝘺. 𝘛𝘩𝘦 𝘳𝘦𝘤𝘰𝘮𝘮𝘦𝘯𝘥𝘢𝘵𝘪𝘰𝘯𝘴 𝘪𝘯 𝘐𝘚𝘖 10993-18:2020 𝘥𝘦𝘴𝘤𝘳𝘪𝘣𝘦 𝘢𝘯 𝘶𝘯𝘤𝘦𝘳𝘵𝘢𝘪𝘯𝘵𝘺 𝘧𝘢𝘤𝘵𝘰𝘳 (𝘜𝘍) 𝘵𝘩𝘢𝘵 𝘴𝘩𝘰𝘶𝘭𝘥 𝘣𝘦 𝘶𝘴𝘦𝘥 𝘵𝘰 𝘦𝘯𝘴𝘶𝘳𝘦 𝘵𝘩𝘢𝘵 𝘵𝘩𝘦 𝘶𝘯𝘤𝘦𝘳𝘵𝘢𝘪𝘯𝘵𝘺 𝘳𝘦𝘭𝘢𝘵𝘦𝘥 𝘵𝘰 𝘳𝘦𝘴𝘱𝘰𝘯𝘴𝘦 𝘧𝘢𝘤𝘵𝘰𝘳 𝘷𝘢𝘳𝘪𝘢𝘵𝘪𝘰𝘯 𝘥𝘰𝘦𝘴 𝘯𝘰𝘵 𝘤𝘢𝘶𝘴𝘦 𝘰𝘮𝘪𝘴𝘴𝘪𝘰𝘯 𝘰𝘧 𝘸𝘦𝘢𝘬𝘭𝘺 𝘳𝘦𝘴𝘱𝘰𝘯𝘥𝘪𝘯𝘨 𝘤𝘰𝘮𝘱𝘰𝘶𝘯𝘥𝘴 𝘱𝘳𝘦𝘴𝘦𝘯𝘵 𝘢𝘣𝘰𝘷𝘦 𝘵𝘩𝘦 𝘢𝘯𝘢𝘭𝘺𝘵𝘪𝘤𝘢𝘭 𝘦𝘷𝘢𝘭𝘶𝘢𝘵𝘪𝘰𝘯 𝘵𝘩𝘳𝘦𝘴𝘩𝘰𝘭𝘥 (𝘈𝘌𝘛). 𝘛𝘩𝘦 𝘳𝘦𝘤𝘰𝘮𝘮𝘦𝘯𝘥𝘢𝘵𝘪𝘰𝘯𝘴 𝘪𝘯𝘤𝘭𝘶𝘥𝘦 𝘥𝘦𝘴𝘤𝘳𝘪𝘱𝘵𝘪𝘰𝘯𝘴 𝘰𝘧 𝘩𝘰𝘸 𝘵𝘩𝘦 𝘜𝘍 𝘤𝘢𝘯 𝘣𝘦 𝘥𝘦𝘳𝘪𝘷𝘦𝘥, 𝘢𝘯𝘥 𝘰𝘯𝘦 𝘱𝘰𝘴𝘴𝘪𝘣𝘭𝘦 𝘮𝘦𝘵𝘩𝘰𝘥 𝘧𝘰𝘳 𝘵𝘩𝘦 𝘢𝘱𝘱𝘭𝘪𝘤𝘢𝘵𝘪𝘰𝘯 𝘰𝘧 𝘵𝘩𝘦 𝘜𝘍 𝘪𝘴 𝘪𝘮𝘱𝘭𝘪𝘦𝘥. 𝘛𝘩𝘦 𝘦𝘲𝘶𝘢𝘵𝘪𝘰𝘯 𝘱𝘳𝘰𝘷𝘪𝘥𝘦𝘥 𝘪𝘮𝘱𝘭𝘪𝘦𝘴 𝘵𝘩𝘢𝘵 𝘜𝘍 𝘤𝘰𝘶𝘭𝘥 𝘣𝘦 𝘢𝘱𝘱𝘭𝘪𝘦𝘥 𝘵𝘰 𝘵𝘩𝘦 𝘈𝘌𝘛 𝘪𝘯 𝘶𝘯𝘪𝘵𝘴 𝘰𝘧 𝘤𝘰𝘯𝘤𝘦𝘯𝘵𝘳𝘢𝘵𝘪𝘰𝘯. 𝘛𝘩𝘪𝘴 𝘮𝘦𝘵𝘩𝘰𝘥 𝘩𝘢𝘴 𝘴𝘰𝘮𝘦 𝘵𝘦𝘤𝘩𝘯𝘪𝘤𝘢𝘭 𝘱𝘳𝘰𝘣𝘭𝘦𝘮𝘴 𝘵𝘩𝘢𝘵 𝘤𝘢𝘯 𝘤𝘢𝘶𝘴𝘦 𝘴𝘪𝘨𝘯𝘪𝘧𝘪𝘤𝘢𝘯𝘵 𝘦𝘳𝘳𝘰𝘳𝘴 𝘪𝘯 𝘵𝘩𝘦 𝘤𝘩𝘦𝘮𝘪𝘤𝘢𝘭 𝘤𝘩𝘢𝘳𝘢𝘤𝘵𝘦𝘳𝘪𝘻𝘢𝘵𝘪𝘰𝘯 𝘳𝘦𝘴𝘶𝘭𝘵𝘴. 𝘛𝘩𝘦 𝘢𝘶𝘵𝘩𝘰𝘳𝘴 𝘸𝘪𝘭𝘭 𝘱𝘳𝘦𝘴𝘦𝘯𝘵 𝘢𝘯 𝘢𝘭𝘵𝘦𝘳𝘯𝘢𝘵𝘪𝘷𝘦 𝘮𝘦𝘵𝘩𝘰𝘥𝘰𝘭𝘰𝘨𝘺, 𝘵𝘩𝘦 𝘢𝘱𝘱𝘭𝘪𝘤𝘢𝘵𝘪𝘰𝘯 𝘰𝘧 𝘵𝘩𝘦 𝘜𝘍 𝘵𝘰 𝘵𝘩𝘦 𝘥𝘪𝘳𝘦𝘤𝘵 𝘪𝘯𝘴𝘵𝘳𝘶𝘮𝘦𝘯𝘵𝘢𝘭 𝘴𝘪𝘨𝘯𝘢𝘭 (𝘱𝘦𝘢𝘬 𝘢𝘳𝘦𝘢). 𝘉𝘰𝘵𝘩 𝘮𝘦𝘵𝘩𝘰𝘥𝘰𝘭𝘰𝘨𝘪𝘦𝘴 𝘸𝘦𝘳𝘦 𝘱𝘦𝘳𝘧𝘰𝘳𝘮𝘦𝘥 𝘢𝘯𝘥 𝘤𝘰𝘮𝘱𝘢𝘳𝘦𝘥 𝘧𝘰𝘳 𝘢 𝘭𝘢𝘣𝘰𝘳𝘢𝘵𝘰𝘳𝘺 𝘴𝘵𝘶𝘥𝘺 𝘱𝘦𝘳𝘧𝘰𝘳𝘮𝘦𝘥 𝘸𝘪𝘵𝘩 𝘤𝘩𝘦𝘮𝘪𝘤𝘢𝘭𝘴 𝘬𝘯𝘰𝘸𝘯 𝘵𝘰 𝘣𝘦 𝘱𝘳𝘦𝘴𝘦𝘯𝘵 𝘯𝘦𝘢𝘳 𝘈𝘌𝘛 𝘪𝘯 𝘢 𝘴𝘪𝘮𝘶𝘭𝘢𝘵𝘦𝘥 𝘦𝘹𝘵𝘳𝘢𝘤𝘵. 𝘛𝘩𝘦 𝘤𝘰𝘮𝘱𝘭𝘦𝘵𝘦 𝘳𝘦𝘴𝘶𝘭𝘵𝘴 𝘧𝘳𝘰𝘮 𝘢 𝘮𝘦𝘥𝘪𝘤𝘢𝘭 𝘥𝘦𝘷𝘪𝘤𝘦 𝘦𝘹𝘵𝘳𝘢𝘤𝘵𝘢𝘣𝘭𝘦𝘴 𝘴𝘵𝘶𝘥𝘺 𝘸𝘦𝘳𝘦 𝘢𝘭𝘴𝘰 𝘤𝘰𝘮𝘱𝘢𝘳𝘦𝘥 𝘧𝘰𝘭𝘭𝘰𝘸𝘪𝘯𝘨 𝘢𝘱𝘱𝘭𝘪𝘤𝘢𝘵𝘪𝘰𝘯 𝘰𝘧 𝘵𝘩𝘦𝘴𝘦 𝘵𝘸𝘰 𝘜𝘍 𝘢𝘱𝘱𝘭𝘪𝘤𝘢𝘵𝘪𝘰𝘯 𝘮𝘦𝘵𝘩𝘰𝘥𝘰𝘭𝘰𝘨𝘪𝘦𝘴. 𝘛𝘩𝘦 𝘱𝘰𝘵𝘦𝘯𝘵𝘪𝘢𝘭 𝘱𝘪𝘵𝘧𝘢𝘭𝘭𝘴 𝘰𝘧 𝘵𝘩𝘦𝘴𝘦 𝘜𝘍 𝘢𝘱𝘱𝘭𝘪𝘤𝘢𝘵𝘪𝘰𝘯 𝘮𝘦𝘵𝘩𝘰𝘥𝘴 𝘸𝘦𝘳𝘦 𝘦𝘹𝘱𝘭𝘰𝘳𝘦𝘥 𝘢𝘯𝘥 𝘸𝘪𝘭𝘭 𝘣𝘦 𝘩𝘪𝘨𝘩𝘭𝘪𝘨𝘩𝘵𝘦𝘥. RQM+ #ExtractablesAndLeachables #MedicalDevices #PatientSafety #RegulatoryCompliance #MedTech