Avsnitt
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While we believe you will find Nancy's story and advice inspiring without visuals, we encourage you to watch the video version containing a brief presentation on the RQM+ website here.
In this heartfelt and insightful video presentation, now available on our blog, Nancy Morrison, RAC shares her journey and the lessons she's learned along the way. Nancy is as highly a respected professional as you'll 𝘦𝘷𝘦𝘳 find in regulatory affairs and as she embarks on her well-deserved retirement, she generously takes the time to impart her wisdom and provide guidance to those aspiring to build a successful career in regulatory affairs. 👩🏫
In her presentation, which features a brief introduction from RQM+ VP of Global Regulatory Affairs, Jaishankar Kutty, Ph.D., Nancy discusses the importance of embracing challenges, building credibility, and fostering positive relationships with colleagues and regulatory bodies. She emphasizes the significance of understanding the "why" behind regulations and encourages others to seek new opportunities and innovative approaches.
She also shares the story of her son Matthew, who relies on numerous medical devices daily. This personal connection underscores the crucial role regulatory affairs professionals play in ensuring the safety and effectiveness of products that directly impact patients' lives. 🦼
We believe Nancy's insights and personal story will inspire everyone, but especially those in RA/QA. Her words can help guide your own career path and help you to navigate the complexities of the regulated industry with confidence and purpose.
And from RQM+, Nancy... we couldn't possibly put into words how much we appreciate you and the positive contributions you've made to our clients over the years. You've changed the MedTech industry for the better in immeasurable ways. Thank you. 🙏
With that said, she's not done yet! Join Nancy on Tuesday, 16 April for her live webinar: Aligning Your QMS with the FDA's QMSR Updates. See this link for more information and to register (or watch on demand after 16 April).
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This show was recorded 28 March 2024. We encourage you to download the presentation given in the first portion of this session by completing the form on this page. Please join us live for future shows and ask your own questions! We hold one RQM+ Live! panel discussion per month and you can sign up at the Knowledge Center or Events pages at RQMplus.com.
Thank you for tuning in. 🙏
Summary
The conversation in this part focuses on the importance of quality systems and compliance in preventing negative impacts on customers, patients, and reputation. The panelists discuss the history and evolution of FDA regulations for medical devices, the potential consequences of not following these regulations, and the need for a strong quality culture within organizations. They also highlight the significance of effective communication, continuous improvement, and proactive remediation activities in staying ahead of compliance risks and device recalls. The conversation highlights the importance of making quick decisions in the medical device industry, especially when it comes to recalls and addressing patient risk. It is crucial to have a concise committee with the right players and a designated decision-maker. Organizations should err on the side of being conservative and prioritize patient safety over financial concerns. Complaint handling and CAPA (Corrective and Preventive Actions) are key components of a robust quality management system. It is important to have a culture of quality that starts from the top and encourages open communication and collaboration. Internal audits and continuous inspection readiness are essential for maintaining compliance and reducing the cost of non-quality. Lack of leadership accountability is identified as a significant barrier to creating a culture of quality.
Takeaways
Quality systems and compliance are crucial in preventing negative impacts on customers, patients, and reputation. Understanding the history and evolution of FDA regulations for medical devices provides context for the importance of compliance. Non-compliance with FDA regulations can lead to various consequences, including warning letters, product recalls, import detention, and civil money penalties. A strong quality culture within an organization is essential for maintaining compliance and preventing compliance issues. Effective communication, continuous improvement, and proactive remediation activities are key in staying ahead of compliance risks and device recalls. Quick decisions need to be made in the medical device industry, and a concise committee with the right players and a designated decision-maker is essential. Organizations should prioritize patient safety over financial concerns and err on the side of being conservative when it comes to recalls and addressing patient risk. Complaint handling and CAPA are crucial components of a robust quality management system. A culture of quality that starts from the top and encourages open communication and collaboration is necessary for maintaining high-quality products. Internal audits and continuous inspection readiness are important for staying compliant and reducing the cost of non-quality. Lack of leadership accountability is a significant barrier to creating a culture of quality.Chapters
00:00 Introduction and Overview
04:12 Evolution of FDA Quality System Regulation
07:17 Consequences of Non-Compliance
12:29 FDA 483 Citation Data
29:10 Making Decisions and Recalls
32:31 CAPA and Complaint Handling 39:22
Creating a Culture of Quality
45:01 Takeaways and Conclusion
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Saknas det avsnitt?
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Our Excellence Spotlight interview series celebrates and showcases the remarkable journeys and achievements of RQM+ employees. These employees are committed to technical excellence and make significant positive contributions to our clients' success.
In our newest interview, we're thrilled to showcase Vice President of Strategic Regulatory Affairs, Dr. Sew-Wah Tay. It was tough to share just a single quote from this interview! Jaishankar Kutty, Ph.D. definitely helped bring out the best in Sew-Wah.
With a rich background in science and engineering, Sew-Wah's had an incredible career. She's a master of interdisciplinary innovation and can skillfully navigate regulations and clinical trials... all with a commitment to teamwork.
She also refuses to give up in the face of seemingly impossible challenges. We could share some quotes from her around that but we encourage you to watch the interview to hear them right from Sew-Wah. 🎧
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RQM+ Vice President of Global Regulatory Affairs (and former BSI), Jaishankar Kutty, Ph.D., discusses the process of reviewing clinical evaluation reports (CERs) by notified body reviewers under the EU MDR in our newest video clip.
In the end and more than anything, manufacturers must provide a clear and comprehensive story in their CERs to facilitate the review process. 📖
Highlights:
Notified body reviewers play a crucial role in the review process of clinical evaluation reports (CERs) under the MDR. Manufacturers should appreciate the challenges faced by notified bodies and provide clear and comprehensive information in their CERs. The review process is time-constrained, and reviewers rely on sampling and calibration to navigate through the documentation. Different reviewers may generate different questions based on their background and experience, but the goal is to enable an effective review of the CER.-
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
🧪 With a fascinating career spanning drug development with GSK to addressing ESPN's water issues, RQM+ / Jordi Labs Senior Study Director Adam Eason's journey has shown his willingness to embrace the unknown and leverage seemingly every experience when solving complex scientific problems.
🔬 His diverse experience includes drug development, environmental chemistry, and polymer chemistry testing. In the interview, you'll hear just how important 𝗰𝗼𝗺𝗺𝘂𝗻𝗶𝗰𝗮𝘁𝗶𝗼𝗻 and 𝗽𝗿𝗼𝗯𝗹𝗲𝗺-𝘀𝗼𝗹𝘃𝗶𝗻𝗴 𝘀𝗸𝗶𝗹𝗹𝘀 are in this role as Senior Study Director.
👥 Sharing achievements with this team? 𝗧𝗵𝗮𝘁'𝘀 𝗶𝗺𝗽𝗼𝗿𝘁𝗮𝗻𝘁, 𝘁𝗼𝗼, and leads to a positive work environment and efficient projects.
We hope you'll join us in celebrating Adam's impactful contributions to RQM+ / Jordi Labs clients and the inspiration he offers his teammates! 🙏
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
Our newest Excellence Spotlight interview is with Noel Keegan, a central figure in RQM+ clinical trial services. Noel is Sr. Director of Data Operations and has expertise that bridges gaps between data management, clinical operations, and regulatory compliance. His forward-thinking approach has elevated our clinical trial methodologies and consistently ensured the success and integrity of our trials.
Starting with a pharmacology degree and skills as an excellent project manager, Noel's career is like many at RQM+: connecting scientific rigor with operational excellence.
🤝 A Belief in Partnership: Noel thrives on building empowered teams and fostering transparent, collaborative relationships with clients. His approach is about being "proactively reactive," anticipating needs, and customizing solutions to fit each unique project.
🔥 Inspiring to Others: Beyond the accolades, Noel finds joy in mentoring, inspiring his teams, and contributing to groundbreaking medical advancements. He knows when his team shines, he does as well.
🌱 Advice for the Future: To those embarking on their journey in clinical research or data management, Noel emphasizes flexibility, open-mindedness, and courage to use one's unique skills to innovate and improve project delivery.
Noel has contributed a significant amount to clinical research and data management for our clients at RQM+ and it's an honor for us to celebrate that in this interview. 🙏
Thank you to Jaishankar Kutty, Ph.D. for conducting the interview as well!--
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
🔬 Kaitlin Lerner is "that chemist" with a Gibbs free energy tattoo. As Director of Operations, she's also one of the most brilliant minds on the RQM+ Lab Services / Jordi Labs team.
In this week's Excellence Spotlight interview, she shares her fascinating journey with Lab Services Chief of Staff, Christine Santagate, RAC (welcome to the Excellence Spotlight, Christine 👋).
🎓 With roots deeply planted in analytical and physical chemistry from Boston College and a Master's from Illinois Institute of Technology, Kaitlin's dedication to mastering the science behind medical devices and pharmaceuticals – paired with her passion for improving lab operations – has led to truly transformative (no exaggeration) innovations at RQM+ / Jordi Labs.
Kaitlin is an enormous reason RQM+ / Jordi Labs is often referred to as the ‘Gold Standard’ in extractable-leachable testing and is held in extremely high regard by the FDA.
🧽 Her advice to aspiring scientists? Be a sponge. Absorb knowledge, engage in diverse projects, and never shy away from asking why. This curiosity and commitment to continuous learning is why Kaitlin is at the forefront of her field today.
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
Yesterday, we published a clip of RQM+ Senior Consultant Anastassia Young, MS discussing our recent conversation with the FDA related to Adverse Event (AE) Reporting. Today, it's time to shine the spotlight on her and only her in our newest Excellence Spotlight. 🔦
A quick glance at what Anastassia brings to RQM+ and our clients:
🔍 Technical Savvy and Storytelling: Her impressive background in science and medicine, enriched by her experiences from Kyrgyzstan to New York University, empowers her to provide incredible value to RQM+ clients and regulatory bodies alike.
💡 From Clinical Medicine to Regulatory Expertise: Transitioning from a prospective medical career to leading in regulatory affairs, she uses her clinical insights to drive innovation and provide cutting-edge solutions for our clients.
🤝 Relationships and Empowerment: Rooted in the importance of relationships, Anastassia fosters a culture of success and confidence within her team. Collaboration and empowerment are words you'll hear often at RQM+, and Anastassia is no exception.
Please feel free to comment and join us in celebrating Anastassia's wonderful story and the meaningful impact she has on RQM+, our clients, and the wider MedTech community. 🙏
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Are you navigating adverse event (AE) reporting in post-market clinical follow-up (PMCF) studies?
In a recent discussion with the FDA, we've uncovered valuable insights into exemptions and variances for AE reporting that could significantly reduce your reporting burden. This collaboration between RQM+ and the FDA paves the way for a more efficient process, allowing for the submission of a single summary report for AE data collected in PMCF studies.
🍿 You'll want to watch for...
Valuable FDA Insights: Learn about exemptions and variants for AE reporting.
Efficient Data Collection: Discover how surveying healthcare providers and analyzing anonymous patient data leads to meaningful AE data collection.
FDA Collaboration: Understand the FDA's approach to determining reporting requirements and encouraging the proactive collection of real-world data.
Streamlined Reporting Process: A single summary report could replace multiple individual reports, easing the burden on manufacturers.
From exemptions and variances to collaborative reporting efforts, this discussion between Anastassia Young, MS and Jaishankar Kutty, Ph.D. is packed with valuable information that can help your company navigate the AE reporting more effectively.
🕒 Jump to a specific segment in the video:
00:00 Introduction and Background
01:00 FDA Discussion on Adverse Event Reporting
03:05 Exemptions and Variants for Reporting
04:26 Collaboration with FDA for Reporting
05:14 Streamlining Reporting Process
06:11 Summary and Blog Announcement
07:06 FDA's Mission and Collaboration-
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This show was recorded 22 February 2024. We encourage you to download the supplemental PDF content for this session by completing the form on this page. Please join us live for future shows and ask your own questions! We hold one RQM+ Live! panel discussion per month and you can sign up at the Knowledge Center or Events pages at RQMplus.com.
Thank you for tuning in. 🙏
Summary
The panelists discuss the requirements for claiming equivalence under the MDR and provide examples of devices that are impacted. They also address actionable steps and next steps for manufacturers. The discussion covers the importance of PMCF studies and the evidence levels required. The panelists also clarify the requirements for claiming equivalence to devices with expired CE marks and within product families. The conversation covers topics such as technical equivalence and benchtop testing data, PMCF studies and registries, changes in PMCF under MDR, the difference between level 3 data producing registries and level 4 data producing retrospective studies, the purposes of registries and surveys, accessing data without a contract, the need for sufficient clinical evidence, acceptance of the new interpretation by notified bodies, reviewers' perspective on equivalence, the timing of the guidance, and action items for manufacturers.
Takeaways
Manufacturers can claim equivalence with other devices to leverage their clinical data, even for new devices. The MDCG 2023-7 guidance clarifies the requirements for claiming equivalence under the MDR. PMCF studies must generate level four data for class three and implantable devices. Claiming equivalence to devices with expired CE marks can be high-risk and should be approached with caution. Claiming equivalence within product families requires careful consideration of the differences in materials and clinical indications. Technical equivalence requires connecting a story with appropriate data. PMCF studies have changed under MDR, with the nomenclature shifting from proactive and reactive to general and specific activities. Registries provide continuous data over the lifetime of a device, while surveys offer a snapshot in time. Manufacturers can access data without a contract by relying on publicly available information, reverse engineering, or comparative testing. The need for sufficient clinical evidence and the requirement to demonstrate clinical, technical, and biological equivalence remain unchanged. Notified bodies are accepting the new interpretation of equivalence. Manufacturers should revisit their product portfolios and consider leveraging the new guidance. Understanding the nuances of the guidance document is crucial. Manufacturers should have discussions with their notified bodies to align on the application of the guidance. Consider salvaging indications for devices that have been narrowed and explore the possibility of conducting PMCF studies. Read the guidance document thoroughly and seek expert assistance if needed.Chapters
00:00 Introduction and Agenda 01:06 Introduction to RQM Plus 01:31 Introduction to Panelists 10:09 Examples of Devices Impacted 21:26 PMCF Studies and Evidence Levels 25:03 Claiming Equivalence to Devices with Expired CE Marks 28:50 Claiming Equivalence to Multiple Manufacturers and Devices 32:18 Claiming Equivalence within Product Families 35:00 Technical Equivalence and Benchtop Testing Data 35:30 PMCF Studies and Registries 36:36 Changes in PMCF under MDR 37:32 Level 3 Data Producing Registries vs Level 4 Data Producing Retrospective Studies 39:04 Different Purposes of Registries and Surveys 40:29 Accessing Data without a Contract 43:05 What Hasn't Changed: Need for Sufficient Clinical Evidence 44:20 Acceptance of the New Interpretation by Notified Bodies 46:17 Reviewers' Perspective on Equivalence 52:28 Timing of the Guidance and Revisiting Product Portfolio 55:05 Action Items for Manufacturers--
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
🌌 Meet the supremely talented Song Seto, PhD, RAC in our latest Excellence Spotlight interview. Song is a Principal in our RA/QA practice.
With a rich background from University of California, Berkeley and Georgia Institute of Technology, as well as experience as a lead reviewer at the FDA, Song's journey is impressive... and this is exactly the experience and capability she brings to RQM+ clients.
📜 Regulatory Expertise: Song brings exceptional regulatory knowledge to the table, navigating the landscape of EU MDR submissions with precision. Her work is instrumental in guiding our clients through the intricate processes, ensuring compliance.
✍️ Masterful Technical Writer: Whether it's grant writing for space science or crafting medical device documentation, Song's ability to convey complex ideas with clarity is superb.
🧠 Mathematical Prowess: Song's interest in mathematics isn't just a hobby—it's a tool in her arsenal, helping her to creatively solve regulatory challenges with a unique analytical rigor.
🌟 Impact on RQM+ Clients: Song's contributions have been pivotal. From leading successful EU MDR submissions to offering strategic regulatory advice/consulting, she has continually elevated our client's projects.
Watch the interview and discover more about how Song's blend of scientific rigor, regulatory expertise, and passion for continuous learning make her a cornerstone of RQM+'s success.
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Summary
This discussion provides a high-level overview of the current state of artificial intelligence (AI) in in vitro diagnostics (IVDs).
The conversation between Director of IVD Intelligence and Innovation, Margot Borgel, and Principal Regulatory Scientist, Bethany Chung, Ph.D., RAC, covers several aspects of AI in IVDs, including its use in diagnosis and predictive algorithms, aiding in the diagnostic workflow, supporting performance testing, and assisting in regulatory efforts. The importance of considering the global view of AI – including public opinion, diversity, privacy, and cybersecurity – is also highlighted.
Takeaways
AI is rapidly growing in the field of IVDs, with a significant increase in the number of AI-based medical devices being approved by regulatory authorities. AI is used in IVDs for diagnosis and predictive algorithms, aiding in the diagnostic workflow, supporting performance testing, and assisting in regulatory efforts. Regulatory workflows can be enhanced with AI, including software that aids in literature reviews, aligns regulatory documents, and assists with PMS analysis. Considering the global view of AI in IVDs is crucial, including addressing bias, ensuring diversity in training data, complying with privacy laws, and prioritizing cybersecurity.Chapters (Approximate)
00:00 Introduction and Current State of AI in IVDs 05:20 AI in IVDs: Diagnosis and Predictive Algorithms 12:18 AI in IVDs: Aiding in the Diagnostic Workflow 15:48 AI in IVDs: Supporting Performance Testing 24:45 AI in IVDs: Supporting Regulatory Efforts 30:23 Global View of AI in IVDs-
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
🔬 Meet RQM+ Director of Biological Evaluation Consulting, Taryn Meade, in our latest Excellence Spotlight interview!
Jaishankar Kutty, Ph.D. describes her as "elegant, talented, quietly confident, and always understated," but we're not going to be understated here! It's time to deservedly shine the spotlight on Taryn and what she brings to RQM+ and our lab clients.
With a decade in medical device and pharmaceutical development, Taryn stands out as an undeniable expert in biological safety evaluation. Taryn comes to RQM+ from the esteemed Jordi Labs, who was acquired by RQM+ in 2022.
Some highlights 🔦
🥼 Lab Expertise: Taryn's unparalleled skill set in the laboratory is matched only by her deep understanding of bioethics and ISO 10993 standards. Her critical role in guiding RQM+ clients through challenging regulatory landscapes is nothing short of impressive.
🧪 Critical Thinking: With a foundation in chemistry and a knack for logical analysis, Taryn anticipates challenges and produces strategic solutions that ensure product safety and compliance, setting her apart in the biocompatibility field.
📖 A Passion for Learning: Taryn's career trajectory is marked by a relentless pursuit of knowledge, tackling new challenges and expanding her expertise beyond her comfort zone. Learn more in the interview!
🛡️ Bioethical Strength: Above all, Taryn's unwavering commitment to patient safety and ethical compliance underscores her role as an admirable leader. Taryn's exceptional lab prowess not only elevate our lab services team and capabilities, but ensure RQM+ remains at the forefront of delivering industry-leading safety evaluations for our clients.
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We deliver full lifecycle materials science and chemical characterization capabilities. RQM+ / Jordi Labs is often referred to as the ‘Gold Standard’ in extractable-leachable testing and is held in extremely high regard by the FDA. Our expertise spans from conceptual bench top testing and prototyping through design verification and validation, preclinical testing, and post-market lifecycle management.
Services include:
Material and Chemical Characterization Toxicological Risk Assessments Extractable-leachable Analysis Biological Evaluations Polymer Investigation Expert Scientific Consulting Across the Development Lifecycle and Post-Market PhaseLearn more and book a consultation with us here.
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📢 Hear Jaishankar Kutty, Ph.D.'s four-minute summary on MDCG 2023-7 and how you can benefit from attending next week's RQM+ Live! panel discussion: New Clinical Evidence Pathways for Legacy and New Devices.
🎟️ RSVP for the 22 February event here.
Why are we talking about this?
To address and clarify potential misinterpretations of Article 61, Items 4, 5, and 6, highlighted by the formation of an MDCG task force.
End goal of next week's panel?
To answer audience questions and provide a robust discussion that leads to a renewed understanding of equivalence in the EU for everyone who attends.
🔗 RSVP and we'll email connection details. We'll be sharing exclusive content with those who sign up.
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🎟️ RSVP for the 22 Feb. panel and get exclusive content.
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🏥 In connection with the FDA’s recent approval of Edwards Lifesciences’ transcatheter tricuspid valve replacement device, here is some commentary from RQM+ Vice President of Intelligence & Innovation, Jaishankar Kutty, Ph.D., about the importance of the benefit-risk story within the target patient population under the aegis of the state of the art and standard of care, in justifying the quantity of clinical data.
Jai also discusses certain aspects of uncertainty that will face other followers in this technology space. Finally, there is time spent on some critical post-market areas that regulators could be focusing on for this device, and they they almost certainly will be focusing on for other devices to follow (perhaps in the pre-market phase). 📊
🕒 Timestamps if you'd like to jump ahead:
00:00 Introduction and Basis of Approval
03:22 Clinical Data and Outcomes
06:14 Regulatory Uncertainties for Device Manufacturers
10:33 Post-Market Areas of Focus for Regulators-
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
From bioengineering student at the University of Pittsburgh to PMCF study leader, meet Garrett Jeffries, PhD in our newest Excellence Spotlight interview.
A snapshot of Garrett’s background and impact to RQM+ clients:
🔬 Bioengineering Brilliance: Garrett has built a career that blends engineering expertise with clinical savvy. His work has spanned the full spectrum of device development, and notably embodies a holistic approach to innovation in the pulmonary space.
📊 Clinical Evaluation Know-How: As a pivotal figure in navigating EU MDR, Garrett has sharp insight when it comes to clinical evaluations and post-market data generation for legacy devices. A theme across many RQM+ consultants: His knack for transforming complex regulatory challenges into straightforward solutions has made him an indispensable asset to manufacturers facing the demands of EU MDR compliance.
📝 Exceptional Analytical Writing Skills: Garrett’s transition from the lab to leading PMCF studies illustrates his ability to critically analyze data and articulate findings. His writings not only meet standards, but exceed them when it comes to clinical and post-market documentation, setting a high benchmark for quality.
Garrett's journey at RQM+ underscores the value of interdisciplinary expertise in regulatory. His work positions our clients to succeed in the near- and long-term as industry requirements evolve. His ongoing contributions continue to set the standard for clinical and post-market excellence at RQM+.
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
📜 Elizabeth Starling went from law school aspirations to becoming a force in regulatory affairs and clinical research as a Senior Consultant at RQM+. Hear her story in our newest Excellence Spotlight interview.
Just a snippet of what sets Elizabeth apart:
🧠 Deep Regulatory Knowledge: With a background that combines legal savvy with regulatory expertise, Elizabeth can dissect the most intricate compliance challenges and offer strategic solutions that drive client success.
✍️ Exceptional Writing Ability: Elizabeth has a knack for translating complex regulatory requirements into compelling narratives that not only meet compliance standards, but also strategically position products for market success. This is key for clarifying the path to approval for cutting-edge medical technologies.
🔝 Setting the Standard: Elizabeth leads by example and her teams complete projects at the highest level of quality. Her leadership directly contributes to RQM+'s reputation for delivering excellence in RA/QA consulting.
Elizabeth’s story is definitely a reminder of how versatility and a willingness to embrace change can lead to unexpected and rewarding paths. Her contributions to RQM+ our clients have not just enhanced our capabilities, but have ensured RQM+ stays at the forefront of MedTech.
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💬 New MedTech Voices Episode: Sally Sennitt and Jaishankar Kutty, Ph.D. dissect the expert panel's review of a groundbreaking extravascular implantable cardiac defibrillator (ICD) and offer insights into regulatory challenges and cardiac care innovation.
Takeaways: 👇
Expert Review Insights for a Novel Extravascular ICD: Get an insider's perspective on the stringent review process by the EU expert panel, including the critical evaluation of safety, efficacy, and novel features of the device.
Data Analysis Deep Dive: Discover the importance of comprehensive data in device approval, from early feasibility studies to pivotal trial results, and how this impacts device certification.
Navigational Guide for Manufacturers: Essential strategies for #MedTech manufacturers on conducting clinical trials, ensuring regulatory compliance, and addressing the expert panel's concerns to accelerate innovation to market.
Future of Cardiac Devices: Engage with these two thought leaders (please ask questions in the comments if you have them!) on the evolution of cardiac care technologies, the role of continuous data assessment, and the significance of post-market surveillance in validating long-term device performance.
There's a ton to unpack in this one and we hope you come away with value after watching! 🙏
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
🌟 A seasoned expert in global regulatory affairs and project management, Senior Manager Laurie Pettit, PMP shares her journey in our newest Excellence Spotlight interview.
Here's why Laurie is an invaluable asset to RQM+ and our clients:
🌍 Global Regulatory Savvy: From her biology beginnings to navigating the complex pathways of international regulations, Laurie's career spans many roles and geographies. Her deep understanding of global requirements combined with a hands-on approach has been instrumental in guiding RQM+ clients through intricate compliance challenges.
🔬 Scientific Acumen: Laurie's foundation in molecular biology and her initial aspirations in research have shaped her meticulous attention to detail. This scientific precision has been pivotal in her success in managing quality and regulatory processes, ensuring every project meets the highest standards.
🛠️ Project Management Whiz: Transitioning into project management was a natural evolution for Laurie, reflecting her ability to steer complex regulatory submissions and strategic initiatives. Her role as a portfolio owner at RQM+ highlights her expertise in aligning business objectives with regulatory requirements, ensuring client success.
Continuous growth, learning, and adapting to the evolving needs of the MedTech industry perfectly describes Laurie. Like many at RQM+, her ability to bridge the gap between regulatory requirements and business objectives makes her a cornerstone of the team.
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MedTech Moments are a curated selection of the most impactful snippets from our expert panel discussions. This clip was taken from RQM+ Live! #72 – EU MDR Timelines and Fine Lines: Unraveling Critical Transition Nuances to Gain Compliance.
What makes a good EU MDR program from a maintenance perspective?
We answered this question in RQM+ Live! #72, featuring:
Sharmila Gardner – Technical Documentation Manager & Head of UK Approved Body, Intertek Brian Dahl – Vice President of Quality and Regulatory, Starkey Hearing Jaishankar Kutty, Ph.D. Jaishankar (Jai) Kutty, Ph.D. – Vice President, Intelligence & Innovation, RQM+🎥⏯️🕗 Watch the entire panel and see the questions we covered on demand here.
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--- Send in a voice message: https://podcasters.spotify.com/pod/show/deviceadvice/message - Visa fler
