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Device Advice by RQM+ RQM+
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RQM+ industry-leading experts and often special guests discuss regulatory, quality, clinical, lab, and reimbursement challenges MedTech companies are facing.
RQM+ is the world's leading MedTech service provider offering consulting, clinical trial, lab, and reimbursement services, as well as technology solutions to support the entire product lifecycle. With more former FDA, Medicines, and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties.
Please visit RQMplus.com to learn more.
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Noel Keegan on Clinical Data Management | Excellence Spotlight Bonus
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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Nancy Morrison's Keys to Thriving in Regulatory Affairs: Lessons Learned from a 30+ Year Career
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.
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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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Live! #77 – Get Ahead of the Crisis: How Your Quality System Can Prevent Negative Impacts on Customers, Patients, and Reputation
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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Sew-Wah-Tay, Vice President of Strategic Regulatory Affairs | Excellence Spotlight
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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How does a notified body clinical reviewer approach a review? | MedTech Voices
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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Adam Eason, Senior Study Director (Lab Services) | Excellence Spotlight
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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