RQM+ industry-leading experts discuss timely regulatory and quality topics medical device, IVD, and combination product companies are facing. RQM+ is the world's leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. RQMplus.com
The Device Advice by RQM+ podcast is an excellent source of highly-informative discussions about medical devices. Whether you are traveling or simply looking for a background audio while working, this podcast offers great content and expert insights on the current changes and challenges in the medical device space.
One of the best aspects of The Device Advice podcast is the caliber of experts that are featured on each episode. The guests include leading professionals in the medical device industry who provide valuable insights and perspectives. Their expertise adds credibility to the discussions, making it a trustworthy source for information. Additionally, the topics covered in each episode are well-rounded, covering a wide range of subjects related to medical devices such as regulation, quality management, design controls, and more. This ensures that listeners can gain a comprehensive understanding of various aspects within the industry.
Furthermore, the format of the podcast is also commendable. The conversations flow smoothly, allowing for an engaging listening experience. The hosts do an excellent job of facilitating the discussions and ensuring that both experts and listeners can easily follow along. The use of real-life examples and case studies enhances understanding and provides practical applications for listeners.
While there are many positive aspects to The Device Advice podcast, one potential drawback is its focus solely on the medical device industry. While this is beneficial for those specifically interested in this field, it may limit its appeal to a broader audience who might be looking for discussions on general healthcare or other related topics. However, considering that it targets professionals and individuals closely involved with medical devices, this niche focus may not necessarily be seen as a negative aspect.
In conclusion, The Device Advice by RQM+ podcast comes highly recommended for anyone seeking informative discussions on current changes and challenges within the medical device space. With its impressive lineup of experts offering insightful perspectives and practical applications, this podcast provides valuable knowledge to professionals in the field as well as those with a general interest in medical devices. Whether you listen while traveling or have it playing in the background while working, this podcast is a great resource for staying informed and up to date on the latest developments in the medical device industry.
This panel was recorded 20 March 2025. Please join us live in the future and have your own questions answered! You can sign up for these events and see other resources in the Knowledge Center at RQMplus.com.Women's health is finally getting the attention it deserves, yet progress is still slowed by gaps in clinical trial diversity, complex regulatory pathways, and funding challenges.In this RQM+ Live! panel discussion, industry leaders and regulatory experts will share real-world strategies MedTech companies can use to navigate these barriers and bring life-changing innovations to market.Why listen:Unlock Market Opportunities – Women's health is one of the fastest-growing MedTech sectors, with rising investor interest and funding.Gain Regulatory Insights – Understand how evolving regulations impact clinical trials, approvals, and commercialization.Learn from Real-World Success – Hear how industry leaders are overcoming challenges and making an impact.Ask Your Toughest Questions – Engage directly with panelists during the live Q&A.Bring Innovations to Market – Get expert insights on bridging clinical research, regulatory approval, and commercialization.Discussion topics:The Business Case for Women's Health Innovation – Why investors, manufacturers, and regulators are prioritizing this space and what it means for MedTech companies.Clinical Trials and Data Gaps – The urgent need for inclusive research, historical data biases, and evolving regulatory expectations.Regulatory and Market Access Hurdles – Key challenges in securing approval and reimbursement—and how to overcome them.Scaling Women's Health Solutions – Lessons from industry leaders on funding, partnerships, and commercialization strategies.Who should listen:MedTech professionals driving innovation in women's healthRegulatory and quality leaders navigating complex approval pathwaysClinical trial specialists improving diversity and data accuracyInvestors and strategists seeking insights into funding and market growthR&D and product development teams designing women's health solutionsHealthcare policymakers and advocates shaping the future of women's health innovationPanelists and moderator:Marissa Fayer – CEO, Her Health Equity & DeepLook MedicalMegan Callanan – US & Global Regulatory Lead, Natural CyclesStephanie Kladakis – Executive Vice President, Chief Technology and Regulatory Officer, AgNovos BioscienceAlexia Haralambous – Senior Principal, RQM+Jaishankar (Jai) Kutty, Ph.D. – Vice President, Global Regulatory Affairs, RQM+ (moderator)Chapters:00:00 Introduction to Women's Health in MedTech10:09 The Surge in Women's Health Innovation20:08 Regulatory Challenges in Women's Health29:52 The Business Case for Women's Health Innovation33:54 Bridging the Gender Gap in Clinical Trials37:02 Enhancing Diversity in Clinical Trial Recruitment40:08 Understanding Regulatory Misconceptions in Women's Health44:09 Strategic Partnerships for Market Access56:03 Future Directions for Women's Health Innovation--
In the final episode of our Breast Cancer Panel, discover how groundbreaking medical technologies and innovative advancements are transforming breast cancer care. Hear firsthand from employees who share their experiences, hopes, and how MedTech is shaping the future of breast cancer treatment and patient outcomes.--
Join us for part two as our courageous panelists discuss their experiences with breast cancer treatment, the importance of self-advocacy, and their involvement in supporting the breast cancer community. This episode highlights practical insights and the incredible strength found through advocacy.--
In this powerful first part of a three-part series, RQM+ employees bravely share their personal journeys from the moment of diagnosis through the emotional and physical challenges they faced. Their stories offer inspiration, resilience, and valuable insights into the realities of breast cancer diagnosis.--
This is an experiment and AI-generated audio version of edition #51 of our weekly LinkedIn newsletter, the RQM+ Weekly Watch.This summary is automatically generated and should not be considered a direct statement from RQM+. While we strive for accuracy, please know this summary may contain errors. It's also only a brief snapshot of the material from this week's LinkedIn newsletter, which contains much more information.A new edition of the RQM+ Weekly Watch is published on LinkedIn every Tuesday.--
This is an experiment and AI-generated audio version of edition #48 of our weekly LinkedIn newsletter, the RQM+ Weekly Watch.This summary is automatically generated and should not be considered a direct statement from RQM+. While we strive for accuracy, please know this summary may contain errors. It's also only a brief snapshot of the material from this week's LinkedIn newsletter, which contains much more information.For the complete picture, please see the full newsletter here. A new edition is published to LinkedIn every Tuesday.--
In celebration of International Women's Day , we asked our team to talk about the most influential women in their lives.Their stories had us tearing up, tbh.
This is an experiment and AI-generated audio version of edition #47 of our weekly LinkedIn newsletter, the RQM+ Weekly Watch.This summary is automatically generated and should not be considered a direct statement from RQM+. While we strive for accuracy, please know this summary may contain errors. It's also only a brief snapshot of the material from this week's LinkedIn newsletter, which contains much more information.For the complete picture, please see the full newsletter here. A new edition is published to LinkedIn every Tuesday.--
This panel was recorded 30 January 2025.Please join us live in the future and have your own questions answered! You can sign up for these events and see other resources in the Knowledge Center at RQMplus.com.As software and connectivity reshape MedTech, implementing effective cybersecurity measures has become business-critical.Join part two of our expert panel for a practical, strategic discussion that cuts through the complexity of cybersecurity guidance and delivers actionable insights for medical device manufacturers.Our panel of industry experts will provide clear, implementable guidance on:Practical strategies for meeting EU MDR and US FDA cybersecurity requirements - with real-world examples and documentation approachesEssential security considerations for medical devices, IVDs and SaMD developmentHow to integrate cybersecurity requirements into your quality management system from the startStandards for risk management, pre- and post-market considerations that satisfy both regulatory requirements and long-term security objectivesStrategic planning for maintaining security throughout your product lifecycleCommon pitfalls to avoid in cybersecurity implementation and regulatory submissionsThe role of SBOMs (Software Bills of Materials) in achieving transparency and regulatory complianceWho Should Attend:This session is essential for medical device manufacturers, software developers, quality professionals, and regulatory teams working with connected devices or SaMD. Whether you're bringing your first connected device to market or optimizing your current cybersecurity approach, you'll gain practical insights for ensuring both compliance and security.Panelists:Allison Komiyama, Ph.D., RAC – Vice President, MedTech Innovation, RQM+Mirko Raner – Cybersecurity Consultant, RQM+Hrishikesh Gadagkar – Senior Principal, RQM+Moderator:Jaishankar (Jai) Kutty, Ph.D. – Vice President, Global Regulatory Affairs, RQM+Register now to gain practical insights that will help you navigate the evolving cybersecurity landscape with confidence, backed by RQM+'s extensive experience in medical device regulatory compliance and software validation.Part one is available on demand here.Chapters00:00 Introduction to Medical Device Cybersecurity03:21 Navigating FDA Regulations and Cybersecurity11:38 Effective Documentation Frameworks for Cybersecurity15:47 Understanding Medical Device Data Systems (MDDS)24:12 Cybersecurity Challenges for In Vitro Diagnostic (IVD) Devices27:02 Addressing Cybersecurity in Interconnected Devices32:41 Risk Assessment and Cybersecurity Documentation37:12 Understanding FDA Regulations for Medical Devices40:54 Cybersecurity Considerations in Medical Devices42:00 Assessing Cybersecurity Threats and Vulnerabilities49:02 The Role of Risk Analysis in Cybersecurity Documentation56:46 Integrating Cybersecurity and Safety Risk Assessments01:09:53 Future-Proofing Against Cyber Threats--
This panel was recorded 12 December 2024. Please join us live in the future and have your own questions answered! You can sign up for these events and see other resources in the Knowledge Center at RQMplus.com. Thank you for tuning in.
This presentation panel was recorded 21 November 2024. Please join us live for future shows for the chance to participate in the chat and ask your own questions! You can sign up for these events and see more free thought leadership content in the Knowledge Center at RQMplus.com. Thank you for tuning in.
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 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. An 18-yr old McDonald's manager at Purdue University's campus restaurant just so happened to find her
*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
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.
*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* In the final installment of this three-part series, Jaishankar Kutty, Ph.D. concludes the discussion with former FDA lead reviewer Ryan Randall and ex-BSI clinical compliance head Amie Smirthwaite (current RQM+ Senior VP of Scientific Affairs) on the intricacies of successful regulatory submissions in clinical trials. Key topics covered: Critical study design elements that can make or break a regulatory submission Navigating global clinical studies and patient population requirements The importance of ISO 14155 compliance in EU submissions Special considerations for niche and orphan devices US Humanitarian Device Exemption (HDE) pathway insights Future developments in EU pathways for rare disease technologies Strategies for managing studies with limited patient populations These experts provide crucial insights into avoiding common pitfalls in study design and execution, while offering unique perspectives on specialized regulatory pathways for rare diseases and underserved populations. Learn how to navigate these complex regulatory landscapes and optimize your submission strategy for success in both US and EU markets. --
This presentation and panel was recorded 4 October 2024. We encourage you to download the slides presented during this session by completing the form on this page. Please join us live for future shows for the chance to participate in the chat and ask your own questions! We generally hold one RQM+ Live! panel discussion per month (in addition to occasional traditional webinars) and you can sign up for these events and more at the Knowledge Center at RQMplus.com. Thank you for tuning in.
*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* In part two of a three-part series, Jaishankar Kutty, Ph.D. continues the discussion with former FDA lead reviewer Ryan Randall and ex-BSI clinical compliance head Amie Smirthwaite (current RQM+ Senior VP of Scientific Affairs) on the intricacies of successful regulatory submissions in clinical trials. Key topics covered: Challenges in demonstrating safety and performance/efficacy for medical devices Differences between FDA and EU approaches to clinical evidence The impact of evolving device designs on clinical studies Importance of pre-submission meetings with regulatory bodies Complexities of the EU reimbursement landscape Strategies for dealing with small sample sizes in clinical data The shift in the EU regulatory landscape and its impact on manufacturers Whether you're a seasoned professional or new to the field, this discussion offers crucial perspectives on optimizing your regulatory submission strategy for medical devices and IVDs in both the US and EU markets. Don't miss this opportunity to learn from top industry experts and enhance your understanding of the regulatory review process in clinical trials! --
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. ⭐ After highlighting many members of our Jordi Labs, an RQM+ Company team in the past two months, we're returning to RA/QA this week. Today we're delighted to share Jaishankar Kutty, Ph.D.'s
*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* In part one of a three part series, Jaishankar Kutty, Ph.D. hosts former FDA lead reviewer Ryan Randall and ex-BSI clinical compliance head Amie Smirthwaite (current RQM+ Senior VP of Scientific Affairs) to unpack the intricacies of successful regulatory submissions in clinical trials. Key topics covered: Essential stakeholders in the clinical trial approval process for both US and EU markets The importance of early engagement with regulatory bodies and payers Reviewer approaches to clinical data sets and benefit-risk analyses Strategies for navigating failed primary endpoints The balance between statistical and clinical significance in regulatory decision-making Differences in approach between MDD and MDR in the EU The impact of study design and protocol adherence on regulatory review These experts provide invaluable insights into the mindset of regulatory reviewers, offering guidance on how to present clinical data effectively and navigate complex regulatory landscapes. Whether you're a seasoned professional or new to the field, this discussion offers crucial perspectives on optimizing your regulatory submission strategy for medical devices and IVDs in both the US and EU markets. Don't miss this opportunity to learn from top industry experts and enhance your understanding of the regulatory review process in clinical trials! --
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.
*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* In our latest clinical trials video, Manager of Safety Management Melanie Miller joins Jaishankar Kutty, Ph.D. to discuss the
This presentation and panel was recorded 12 September 2024. We encourage you to download the slides presented during this session by completing the form on this page. Please join us live for future shows for the chance to participate in the chat and ask your own questions! We generally hold one RQM+ Live! panel discussion per month (in addition to occasional traditional webinars) and you can sign up for these events and more at the Knowledge Center at RQMplus.com. Thank you for tuning in.
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 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 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.
*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* In our third and final clinical trials video focused on data management, Senior Director of Data Operations Noel Keegan returns to speak with Jaishankar Kutty, Ph.D. about the
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.
*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
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
*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* Explore in vitro diagnostic (IVD) clinical trial site selection and monitoring with our latest videos in our educational video series on clinical trials. In these two videos (this is video 2) specific to site selection and monitoring, RQM+ experts reveal: Key considerations for selecting ideal clinical partners Red flags to watch out for during site selection Best practices for effective trial monitoring Risk-based approaches to remote and on-site monitoring Strategies for data cleaning and accountability Featuring insights from: Margot Borgel - Director, IVD Global Regulatory Affairs Brandy Chittester - Senior Director, Clinical Operations Manali Patel - Clinical Research Associate Whether you're a seasoned professional or new to IVD studies, this video series offers valuable tips to enhance your site selection process and streamline your clinical trials. Reminder that you can find all of our clinical trial videos in other places, too.
*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* Explore in vitro diagnostic (IVD) clinical trial site selection and monitoring with our latest videos in our educational video series on clinical trials. In these two videos (this is video 1) specific to site selection and monitoring, RQM+ experts reveal: Key considerations for selecting ideal clinical partners Red flags to watch out for during site selection Best practices for effective trial monitoring Risk-based approaches to remote and on-site monitoring Strategies for data cleaning and accountability Featuring insights from: Margot Borgel - Director, IVD Global Regulatory Affairs Brandy Chittester - Senior Director, Clinical Operations Manali Patel - Clinical Research Associate Whether you're a seasoned professional or new to IVD studies, this video series offers valuable tips to enhance your site selection process and streamline your clinical trials. Reminder that you can find all of our clinical trial videos in other places, too.
This presentation and panel was recorded 8 August 2024. We encourage you to download Michelle Tarver's presentation slides by completing the form on this page. Please join us live for future shows for the chance to participate in the chat and ask your own questions! We generally hold one RQM+ Live! panel discussion per month (in addition to more traditional webinars) and you can sign up for these events and more at the Knowledge Center at RQMplus.com. Thank you for tuning in.
Our ongoing educational video series on
*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
This was recorded 18 July 2024. We encourage you to download the presentation slides by completing the form on this page. Please join us live for future shows for the chance to participate in the chat and ask your own questions! We generally hold one RQM+ Live! panel discussion per month (in addition to more traditional webinars) and you can sign up for these events and more at the Knowledge Center or Events pages at RQMplus.com. Thank you for tuning in.
*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* While she has moved towards retirement since recording this video with Jaishankar Kutty, Ph.D., Nancy Morrison, RAC talks about the regulatory landmines around
This conversation features a Q&A session with a CAPA-focused team from RQM+ and explores the unique value consultants bring to clients. Our experienced team shares their top skills, dream projects, and what drives them to make a difference in the industry. From problem-solving strategies to personal inspirations, discover how these professionals are shaping the future of medical device quality and regulatory compliance. Whether you're a professional simply interested in the field or a manufacturer interested in potentially leveraging consultant expertise, this conversation offers valuable perspectives. Chapters 00:00 - Introduction to the Team 02:23 - The Difference Between Contractors and Consultants 05:13 - Leveraging Collective Knowledge for Client Success 07:36 - Top Skill Sets for Consulting Success 14:36 - Ideal Projects and Personal Goals Panelists: Elaine M. Ruminski, MS - Senior Consultant Craig McIntire - Senior Consultant Makenzie Dorring - Consultant, CMDA Joe Commane - Consultant Scott Edwards - Managing Director --
*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* Combination Device Clinical Trials: Strategy & Tactics Join RQM+ experts Jaishankar Kutty, PhD and Chad Quistad as they unpack the complexities of combination device clinical trials in this comprehensive educational video. Key topics covered: Definition and examples of combination devices Regulatory pathways in the US and EU Product development challenges unique to combination products Essential documentation for robust trial design Critical considerations for successful trial execution Highlights include: The importance of cross-functional expertise in drug and device development Crucial pre-trial steps: usability studies, risk analysis, and early stability testing Strategies for overcoming common trial execution challenges Real-world case study demonstrating the value of proactive testing Whether you're new to combination devices or looking to optimize your approach, this video offers valuable insights to enhance your clinical trial strategy. Reminder that you can find all of our clinical trial videos in other places, too.
*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* ✏️
*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* ❓ How do you effectively
This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials. ❓ What are the CGMP principles and traceability requirements for
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