Device Advice by RQM‪+‬ RQM+

This show was recorded 25 April 2024. We encourage you to download the IVDR timeline presented at the beginning 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.

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Summary


In this conversation, panelists discuss the crucial role of Notified Bodies in the EU regulatory environment for IVDs and medical devices. They highlight the challenges faced by manufacturers due to changing regulations and the consultative nature of Notified Bodies, emphasizing the differences between the decentralized EU regulatory structure and the US system.



The panelists provide updates on the extended transition timelines for IVDR implementation and introduce the concept of structured dialogue as a means to address uncertainties and provide clarity for manufacturers. They also delve into the importance of governance for Notified Bodies in assessing regulatory changes and ensuring compliance.



The expertise and qualifications of Notified Body personnel are emphasized, with a focus on their technical background, skills, and attitude. Manufacturers are encouraged to provide clear and comprehensive technical documentation to facilitate effective interactions with Notified Bodies.



The role of Team NB in harmonizing processes among Notified Bodies is discussed, along with the potential limitations of relying solely on MedTech Europe guidance, which represents industry perspectives and may not fully align with regulatory requirements.



Throughout the conversation, the panelists share their backgrounds and expertise in the IVD and medical device regulatory field, providing valuable insights into the complex landscape of EU regulations and the critical role played by Notified Bodies in ensuring compliance and market access for manufacturers.



Takeaways


Notified Bodies are essential for ensuring compliance and market access for IVDs and medical devices in the EU.
Manufacturers must navigate a challenging and evolving regulatory landscape, working closely with Notified Bodies to address uncertainties and maintain compliance.
Clear technical documentation, expertise, and harmonized processes are key factors in fostering successful interactions between manufacturers and Notified Bodies.
While industry guidance can be helpful, manufacturers must ultimately ensure their compliance with the official regulatory requirements.



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𝗡𝗘𝗪𝗦 → FDA releases final rule on Laboratory-Developed Tests (LDTs) 🚨



RQM+'s Bethany Knorr Chung, PhD, RAC and Margot Borgel, Ph.D. dive into the details of what you need to know, including:



✅ The 4-year phase-in timeline for compliance



✅ Expanded enforcement discretion for certain LDTs



✅ Grandfathering clause for currently marketed LDTs



Watch now to learn how this rule impacts your business and what steps you need to take to ensure compliance.



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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.



🔬 Hot on the heels of Jordi Labs' groundbreaking new publication support for simulated use testing of blood-contacting medical devices, we're thrilled to showcase one of Jordi's shining stars in our 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 series: Meet Samantha Howard, Study Director! 🌟

As an influential voice within Jordi Labs, an RQM+ company, Samantha's deep knowledge and exceptional communication skills have made her a go-to resource for clients seeking solutions to complex problems. Her work directly supports Jordi's mission to 𝗺𝗮𝗸𝗲 𝗰𝗵𝗲𝗺𝗶𝗰𝗮𝗹 𝗰𝗵𝗮𝗿𝗮𝗰𝘁𝗲𝗿𝗶𝘇𝗮𝘁𝗶𝗼𝗻 𝘁𝗲𝘀𝘁𝗶𝗻𝗴 𝗮𝘀 𝗮𝗰𝗰𝘂𝗿𝗮𝘁𝗲 𝗮𝗻𝗱 𝗰𝗼𝗻𝘃𝗲𝗻𝗶𝗲𝗻𝘁 𝗳𝗼𝗿 𝗺𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗲𝘀 𝗮𝘀 𝗽𝗼𝘀𝘀𝗶𝗯𝗹𝗲.



With nearly 7 years of experience at Jordi Labs, Samantha has grown from chemist to project manager to study director, honing her strategic skills along the way. Her thoughtful, focused, and analytical approach brings a 𝗵𝘂𝗺𝗮𝗻 𝗰𝗼𝗻𝗻𝗲𝗰𝘁𝗶𝗼𝗻 to highly technical programs.



🧪📚 In this interview, Samantha shares her passion for analytical chemistry, her dedication to continuous learning, and her advice for those entering the industry. She emphasizes the importance of asking questions, learning from experienced colleagues, and embracing growth opportunities.



We hope you'll join us in celebrating Samantha's achievements and the 𝗽𝗼𝘀𝗶𝘁𝗶𝘃𝗲 𝗶𝗺𝗽𝗮𝗰𝘁 she makes on our clients' success! We think this is a great interview to watch for industry veterans and newbies alike. Watch the full interview to learn more about Samantha.



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In this special bonus clip from our Excellence Spotlight series, Sr. Director of Data Operations (Clinical Trials) Noel Keegan takes a deep dive into clinical data management.



From the transition to electronic systems to the exciting potential of AI, Noel reflects on the evolution he's witnessed over his 16+ year career. He breaks down the key aspects of data management across the study lifecycle:



🏁 Study Start-Up: Collaborating with cross-functional teams to build user-friendly, robust databases with carefully considered edit checks.



🏃‍♂️ Ongoing Maintenance: Proactively cleaning data, generating oversight listings, and locking data progressively to ensure smooth deliverables later on.



🎯 Database Lock: Achieving efficiencies that enable rapid timelines from last patient visit to lock.



Noel also discusses key differences in data management approaches between medical devices, IVDs, and pharma. While the core principles of data reliability and integrity are universal, he notes the generally "lighter touch" in MedTech vs. the extensive external data reconciliation often required in pharma.



This discussion is a great example of the critical thinking required to deliver top-tier data management services customized to each client's unique needs. This is what we do at RQM+. Thank you to Noel for this look at what goes on behind the curtain to ensure the success of the clinical trials we support!

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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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