Vishal Kanani, MS, RAC (US)

😵‍💫 FDA (510k,PMA, de Novo) versus EU MDR notable differences or not the same. Here is our list of FAQ to help you explore the differences between the jurisdictions and conformity routes. #MedTechclearance #Medtech #FDA

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FDA started the new year in a big way by notifying industry of five new draft guidance documents that are applicable to medical device sponsors/manufacturers. The below will be published on January 7th as draft guidance. - Draft guidance: Pulse Oximeters for Medical Purposes - Draft guidance: Artificial Intelligence-Enabled Devices - Draft guidance: Study of Sex Differences in the Clinical Evaluation of Medical Products - 506J Guidance: Notifying FDA About Medical Device Supply Issues (Public Health Emergencies) - Draft Guidance: Validation of IVDs During a Declared 564 Emergency

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🎉 I'm happy to share that I obtained the RCC-MDR certification from Regulatory Affairs Professionals Society (RAPS). The #MDR holds a special place in my heart and has been a major focus of my regulatory career over the last 5 years. 💡 RCC Facts: The Regulatory Compliance Certification (RCC) is a leading credential for #regulatory professionals in the #healthcare product sector. It is intended for individuals employed in regulatory agencies, industry, consultancies and other settings involved with the regulation of healthcare products. Success on the RCC exam requires knowledge of: ✅ Conformity of the Devices 📃 Technical Documentation 🔎 Post-marketing Surveillance ⚖ Vigilance 🔬 Clinical Investigations 

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NIRS monitoring alerts you to critical changes in your patients — but not all technologies respond the same during blood transfusion. When every second counts, which would you choose? Compare response times of leading NIRS technologies. #MedtronicEmployee https://bit.ly/4irSU3P

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#QMSR will be part of the topics that we will discuss in the upcoming course. Want to know more? Talk to me 🤗

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IPM took a multifaceted approach to EU MDR remediation, driving a medical device company to build the staffing, budget, governance, and operations necessary for the critical cross-functional effort. #EUMDR #FromStrategyToExecution https://lnkd.in/gFbzand9

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How prepared is your organization to navigate the complexities of medical device complaint handling?   ECI's recent presentation on this topic by Rita Hoffman, RAC, a former FDA Officer and Branch Chief for over 36 years and a Sr. Fellow Consultant for ECI, was very insightful and is 𝗻𝗼𝘄 𝗮𝘃𝗮𝗶𝗹𝗮𝗯𝗹𝗲 𝗼𝗻 𝗱𝗲𝗺𝗮𝗻𝗱.   Some feedback from folks who recently attended👇   💬 "This presentation has given me so much clarity and confidence on tackling QA/RA. Now, as an Analyst, I am very confident to say that I know the process or rather "Trust the Process."   💬 "I will re-watch this again and make sure I memorize and understand every single fact on how to handle a complaint and be an expert!"   💬 "I have been in the RA/QA industry for about 8 years now and watching this carefully and listening to every single detail of what Rita had shared, it has given so much clarity!" If you missed, 𝐈𝐧𝐬𝐢𝐠𝐡𝐭𝐬 𝐟𝐫𝐨𝐦 𝐚𝐧 𝐅𝐃𝐀 𝐄𝐱𝐩𝐞𝐫𝐭: 𝐌𝐚𝐬𝐭𝐞𝐫𝐢𝐧𝐠 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐂𝐨𝐦𝐩𝐥𝐚𝐢𝐧𝐭 𝐇𝐚𝐧𝐝𝐥𝐢𝐧𝐠, the recording is available at the link below. Contact ECI to learn more. 🖥️ https://lnkd.in/ehR_ZirG

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So excited for this webinar; my boss is leading it, too!✨ Be sure to sign up to learn more about our “day-to-day” as Regulatory Professionals in the world of Total Artificial Hearts (TAHs)! 🫀⚙️ #regulatoryaffairs #totalartificialhearts #hearthackathon

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#FDA Accreditation Scheme for Conformity Assessment (#ASCA) news ❗ ❗ Introduced in 2021, the ASCA program is a voluntary program that allows device manufacturers to use an ASCA-accredited #testing_laboratory to conduct testing to be included in #premarket_submissions to the FDA. The ASCA program is designed to speed up FDA review times, reduce guesswork on documentation to provide in a premarket submission, and improve the quality of testing conducted. The ASCA program includes FDA #recognized_consensus_standards and related test methods across two scopes: 📌 #Biocompatibility: This scope includes standards for testing the safety of medical devices when they come into contact with human tissues. 📌 Basic #safety and #essential_performance: This scope includes standards for testing the safety and performance of medical devices. It’s important to note that medical device manufacturers should continue to reference additional FDA-recognized standards and provide declarations of conformity in their premarket submissions, as standards outside of biocompatibility and basic safety and essential performance are not eligible for ASCA program benefits. ‍ Last week the FDA has published 3 draft guidance's regarding the 'Accreditation Scheme for Conformity Assessment (ASCA)' The following guidance's have been released: • A general draft guidance discussing the goals and implementation of the program- https://lnkd.in/dpudfV3J • A draft guidance focused on biocompatibility testing standards- https://lnkd.in/da3kQsbW • A draft guidance discussing basic safety and essential performance-specific standards- https://lnkd.in/dZv_AsbS These guidance's include updates to the ASCA program based on feedback from public meetings, webinars, stakeholder meetings, and lessons learned internally during the pilot phase. Stay up to date and make sure you leverage #regulatory_intelligence for the benefit of your company. Gsap is here to help. Iris Shamir Mado Otzri Micha Sherzer ☆ Dana Manaim - Tirosh Avital Levertov

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Navigate the complexities of EU MDR compliance for medical devices with this essential guide. 🇪🇺 #EUMDRCompliance https://lnkd.in/gJnkEm4B

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FDA recalls have significantly increased over the last six years and the 🔑 to avoiding one is staying on top of quality management. Learn more about some key components of product recall avoidance in MasterControl's guide here: https://lnkd.in/e_ZhWVxr #drugrecalls #qualitymanagement #lifesciences #FDA

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🔍 Insights on MDR/IVDR Progression II: Gradual Improvements in Submission Completeness? 🤔 Before diving into the details 🔍, let's clarify: we're solely discussing the completeness of submissions. We're not touching on the correctness of classification, technical contents, adequacy of clinical data, or any other aspects. Just the completeness. Meaning, if you're asked to submit A, B, C, and D, your package should indeed include A, B, C, and D. Sounds simple, right? 🤓 When comparing the development of notified body responses from 2023 to this year, we do observe some gradual improvements. 💪 However, the European Commission's statements on the results are quite sobering: 😳 ➡️ MDR: “Incomplete submissions remain high” ➡️ IVDR: “Submissions largely incomplete” What more can we do? 🙄 https://lnkd.in/dh2QxxJE #MDR #IVDR #notifiedbody #TUVSUD

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Great inspectional insights by FDA inspectors Phil Pontikos, Benjamin Dastoli, Monica J. W. on #SupplierQuality, #validation, #riskmanagement, and #DesignTransfer at #Medcon 2024 Notably, FDA is seeing a lot of supplier-related risk, and many OEM’s don’t understand what their suppliers are doing!  Supplier criteria need to be based on a risk management process.  Some key takeaways: -put quality agreements and change notification agreements in place with suppliers -make clear who is responsible for talking to suppliers on Quality issues  -what are the technical requirements your suppliers need to meet to meet your design specs?  *Ravi’s note: follow GHTF N17 for supplier selection prior to supplier qualification, and document selection criteria and results (including which suppliers were NOT selected and WHY), using a cross-functional team for supplier selection  -correlate part risk (from design outputs) to supplier risk  -outsourced software testing : expect questions on “white box testing”, including unit testing  -Contract manufacturers are inspected, but OEM is ultimately responsible  -outsourced design is covered in inspections -in the total grading of suppliers (eg quarterly supplier reviews), the weight placed on Quality is often insignificant in the overall grade; expect inspectors to question this! -what do you do/ have in place for a process if a single source supplier is not performing  well? -be prepared to demonstrate multi- source supplier equivalency ! -issues are seen with auditing a CMO… -CMO (& other suppliers) should have validation evidence -important to transfer risk management documentation to CMO -need to transfer design changes to CMO; need a procedure that’s clear on this; to ensure awareness of associated risks -Essential Design Outputs (EDO) should be tested with the right test method;this is true for both CMO AND sister companies (internal suppliers) #ComplianceGroup provides supplier quality services to ensure #supplierquality, #partquality, #designtransfer to suppliers, #supplieraudits, #suppliervalidation, and assurance of compliance to #purchasingcontrols requirements, including #qualityagreements, and #QMSprocedures to ensure compliance to applicable regulations (#21CFR820.50, #ISO134857.4)

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🚀 Understanding Regulatory Strategy: A Key Factor for SaMD Manufacturers in SWOT Analysis 🚀 For Software as a Medical Device (SaMD) manufacturers, a well-defined regulatory strategy isn’t just a box to check—it’s a crucial asset in navigating both opportunities and challenges. When we consider regulatory factors in a SWOT analysis, it becomes clear how they shape a company’s ability to thrive in a highly regulated environment: 1. Strengths: A strong regulatory strategy gives SaMD manufacturers a competitive edge. Companies that prioritize compliance from the start are better equipped to build trust, deliver safe and effective products, and maintain customer confidence. This approach leads to smoother audits, streamlined product approvals, and faster market access. 2. Weaknesses: Without a solid regulatory framework, even the best innovations can struggle. Lack of preparation for the dynamic regulatory landscape can lead to costly delays, additional development costs, or even withdrawal of products from the market. Identifying these gaps early on can prevent setbacks. 3. Opportunities: Staying ahead of regulatory trends enables manufacturers to anticipate changes and adapt quickly, whether it's through new certifications, expanded product lines, or optimized patient outcomes. With the right strategy, compliance becomes a catalyst for innovation and market leadership. 4. Threats: Regulatory requirements are evolving rapidly, and failing to keep up can jeopardize a company's reputation and viability. SaMD manufacturers who underestimate these shifts or overlook critical regulatory aspects face increased scrutiny, potential fines, and lost market opportunities. Incorporating a proactive regulatory strategy into SWOT analysis allows SaMD manufacturers to transform compliance into a key business driver. By doing so, we not only mitigate risk but also position ourselves to deliver impactful, safe, and compliant products to market. 🌐💡 #SaMD #RegulatoryStrategy #MedTech #SWOTAnalysis #Compliance

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This week the FDA published new draft guidance regarding testing requirements for pulse oximetry devices. At Nonin, we understand the impact of high-quality, accurate oximetry and we are pleased to see the FDA progressing this important issue. I am proud to be a part of the Nonin team, where we work hard every day to provide our patients and caregivers with accurate and high-quality pulse oximeters. https://lnkd.in/gvEjkftw

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🌟 MDCG 2019-13 Rev. 1 Guidance Simplified 🌟 We are excited to share insights into the latest guidance document that outlines essential criteria for sampling and reviewing the technical documentation of MDR Class IIa/IIb and IVDR Class B/C devices. Key highlights include: Representative device sampling before certification to ensure compliance. Annual surveillance and post-market assessments focused on safety and performance. A rigorous review of documentation in line with Annex I-III requirements. Dynamic sampling plans that adapt to evolving product portfolios and compliance needs. Understanding these criteria is vital for manufacturers to navigate regulatory requirements effectively and maintain high safety standards. Stay informed and enhance your compliance strategy! #MDCG #MedicalDevices #MDR #IVDR #RegulatoryCompliance #QualityAssurance #TechnicalDocumentation #DeviceSafety

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