Podcast
Making MedTech Happen with RQM+
Hosted by RQM+ · EN
RQM+ is The MedTech CRO – a full-service partner supporting everything from groundbreaking innovation to well-established technologies. Our coordinated and comprehensive solutions are customized to each client’s product and life cycle stage. By aligning strategy and execution in one partner, we help reduce cost, accelerate timelines, and drive more successful outcomes.
Visit RQMplus.com to see how we help MedTech companies of all sizes, spanning all device types and therapeutic areas.
This podcast provides audio/video we also share on our website and LinkedIn page. Thank you for listening!
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Weekly Watch #47 (AI-Generated, Subscribe On LinkedIn)
Mar 6, 202500:17:11Tap to summarizeThis 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.--📲 Follow RQM+ on LinkedIn.📩 Subscribe to the RQM+ Weekly Watch.💼 Check out our open positions.📚 See on-demand content in our Knowledge Center.📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
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Live! #86 – PART 2: Medical Device Cybersecurity: Proven Strategies for Connected Devices and SaMD
Feb 12, 202501:13:28Tap to summarizeThis 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--📲Follow RQM+ on LinkedIn.💼Check out our open positions.📚See on-demand content in our Knowledge Center.📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to useour contact form.
Transcribe →Live! #85 – Medical Device Cybersecurity: Proven Strategies for Connected Devices and SaMD
Dec 19, 202401:03:14Tap to summarizeThis 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. 🙏 As software and connectivity reshape MedTech, implementing effective cybersecurity measures has become business-critical. Join 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 approaches Essential security considerations for medical devices, IVDs and SaMD development How to integrate cybersecurity requirements into your quality management system from the start Standards for risk management, pre- and post-market considerations that satisfy both regulatory requirements and long-term security objectives Strategic planning for maintaining security throughout your product lifecycle Common pitfalls to avoid in cybersecurity implementation and regulatory submissions The role of SBOMs (Software Bills of Materials) in achieving transparency and regulatory compliance Who 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+ Listen 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. Chapters 00:00 Introduction to Medical Device Cybersecurity 03:17 Understanding Cybersecurity in MedTech 08:14 Defining Cyber Devices and Regulatory Requirements 14:39 Translating Regulatory Guidance into Practical Strategies 22:57 Addressing Audience Questions on Cybersecurity 29:43 Understanding Near Field Communication in Medical Devices 30:44 Navigating Threat Actors in Cybersecurity 31:43 FDA Review Process for Cybersecurity 32:40 Common Deficiencies in Cybersecurity Submissions 34:03 Critical Gaps in Cybersecurity Documentation 37:19 Essential Security Considerations in Device Design 40:00 Integrating Cybersecurity into Development Processes 43:16 Real-World Examples of Cybersecurity in QMS 45:57 Shared Responsibility for Cybersecurity in Healthcare 48:27 Best Practices for Cybersecurity in Medical Devices 51:24 Automating Cybersecurity Vulnerability Assessments 54:58 Exploitability vs. Probability in Risk Management 57:48 Operationalizing Cybersecurity Standards in Development -- 📲 Follow RQM+ on LinkedIn. 💼 Check out our open positions. 📚 See on-demand content in our Knowledge Center. 📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
Transcribe →Live! #84 – Critical Shifts in Biological Evaluation: Inside the New ISO 10993-1 Risk Management Framework
Dec 5, 202400:57:42Tap to summarizeThis 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. 🙏 As significant changes to ISO 10993-1 loom on the horizon, manufacturers across MedTech are seeking clarity on what's coming and how to prepare. Join our expert panel for an essential discussion on these upcoming revisions to ISO 10993-1 and their far-reaching implications for biological evaluation processes. Our panel will provide actionable insights into: The most significant upcoming changes to ISO 10993-1 and their implementation timeline Comprehensive guidance on applying the ISO 14971 device risk management framework to biological evaluation, including, new approaches to risk estimation, considerations for reasonably foreseeable misuse, practical implementation strategies Critical updates to device categorization and their impact on modified biological effects Strategic considerations for maintaining compliance during Panelists: Taryn Meade – Director of Biological Evaluation Stephen Bond – Senior Toxicologist Amanda DeGraw, MS, Ph.D., DABT – Principal Toxicologist Moderator: Christine Santagate, RAC – Vice President of Lab Services Topics with Timestamps: 00:00 Introduction to RQM+ and ISO 10993-1 02:53 Overview of ISO 10993-1 Updates 05:50 Key Changes in Biological Evaluation 08:23 Device Classification and Contact Duration 10:45 Implementation Timeline and Regulatory Considerations 13:32 Risk Estimation and Biological Evaluation 16:41 FDA Guidance and Non-Harmonization Issues 29:09 Navigating Device Categorization and FDA Feedback 31:18 Balancing Testing Burdens and Biological Safety 33:14 Understanding Reasonably Foreseeable Misuse 35:45 Challenges in Risk Assessment and Off-Label Use 39:49 Implementing ISO 14971 in Biological Evaluation 41:31 Modified Biological Effects and Device Categorization 43:31 Addressing Repeated Use of Single-Use Devices 47:16 In-House vs. Outsourced Testing for E&L 50:47 Key Advice for Manufacturers on Upcoming Changes -- 📲 Follow RQM+ on LinkedIn. 💼 Check out our open positions. 📚 See on-demand content in our Knowledge Center. 📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
Transcribe →Chris Parr, Principal Consultant | Excellence Spotlight
Nov 14, 202400:13:23Tap to summarizeOur 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. 🌟 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 interview: Chris A. Parr, PMP With over 20 years in regulatory and quality compliance, Chris exemplifies RQM+'s deep expertise and commitment to our clients. From leading complex FDA 510(k) submissions to building robust EU MDR frameworks post-Brexit, Chris’s strategic insights and leadership are of enormous value to any project. He's quite the bookworm as well! 📚 Hear Chris’s story below and discover how his dedication drives outstanding results for our clients. -- 📲 Follow RQM+ on LinkedIn. 💼 Check out our open positions. 📚 See on-demand content in our Knowledge Center. 📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
Transcribe →Carrie Schneider, Principal Consultant | Excellence Spotlight
Nov 7, 202400:14:35Tap to summarizeOur 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 𝗾𝘂𝗮𝗹𝗶𝘁𝘆 𝗺𝗶𝗻𝗱𝘀𝗲𝘁 📋✓ making consistently perfect burgers. Today, Carrie (Habegger) Schneider is a Principal Consultant at RQM+, with three (!) degrees 📚 earned while raising three (!) kids 👨👩👧👦 Her expertise in 𝗽𝗼𝘀𝘁-𝗺𝗮𝗿𝗸𝗲𝘁 𝘀𝘂𝗿𝘃𝗲𝗶𝗹𝗹𝗮𝗻𝗰𝗲 and 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗲𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝗼𝗻 keeps medical devices safe for patients worldwide. 🏥Watch her relatable and remarkable journey in our latest 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁! -- 📲 Follow RQM+ on LinkedIn. 💼 Check out our open positions. 📚 See on-demand content in our Knowledge Center. 📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
Transcribe →What makes a successful regulatory submission from a clinical trial perspective for IVDs? – MedTech CRO: Regulatory Expertise Series
Nov 4, 202400:09:58Tap to summarize*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 𝗺𝗮𝗸𝗲𝘀 𝗮 𝘀𝘂𝗰𝗰𝗲𝘀𝘀𝗳𝘂𝗹 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝘀𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻 𝗳𝗿𝗼𝗺 𝗮 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹 𝗽𝗲𝗿𝘀𝗽𝗲𝗰𝘁𝗶𝘃𝗲 𝗳𝗼𝗿 𝗜𝗩𝗗𝘀? Did you know 60-80% of IVD 510(k)s require clinical data? In this must-watch video, Director of IVD Global Regulatory Affairs Margot Borgel, Ph.D. is joined by Nancy Morrison, RAC (with 30+ years of regulatory experience) and they break down the make-or-break factors in IVD submissions. 𝗞𝗲𝘆 𝘁𝗮𝗸𝗲𝗮𝘄𝗮𝘆𝘀: – Why clinical data is non-negotiable for modern IVD submissions – Critical FDA & EU regulatory expectations for clinical evidence – How to avoid costly study design mistakes – Smart strategies for patient population selection – Key considerations for diversity in clinical trials – Tips for navigating the IVDR transition period 𝗕𝗼𝗻𝘂𝘀 𝗜𝗻𝘀𝗶𝗴𝗵𝘁: Learn why "baby steps" in regulatory strategy might actually 𝘨𝘦𝘵 𝘺𝘰𝘶 𝘵𝘰 𝘮𝘢𝘳𝘬𝘦𝘵 𝘧𝘢𝘴𝘵𝘦𝘳! Don't miss this expert guidance on avoiding the pitfalls that could force you to restart your entire clinical program. -- 📲 Follow RQM+ on LinkedIn. 💼 Check out our open positions. 📚 See on-demand content in our Knowledge Center. 📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
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Holly Cotter, Senior Consultant | Excellence Spotlight
Oct 28, 202400:14:53Tap to summarizeOur 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 an especially fun one! From National Geographic subscriptions to successfully navigating FDA submissions, meet Senior Consultant Holly Cotter, RAC, CBA. Driven by a palpable curiosity since childhood, she's transformed her love for learning into a thriving hashtag#MedTech career and currently brings 𝙞𝙢𝙢𝙚𝙣𝙨𝙚 value to RQM+ clients. In this spotlight, Holly shares: 🧬 Her path from bioengineering to hands-on clinical experience with artificial hearts 🔬 The valuable lessons learned from working in a 10-person startup 📈 How she turned an FDA "not substantially equivalent" letter into a 32-day clearance win ✍️ Her recent venture into authorship for regulatory publications (hint → Regulatory Affairs Professionals Society (RAPS)) There MIGHT have been a Grey's Anatomy reference, too. Maybe. 😉 -- 📲 Follow RQM+ on LinkedIn. 💼 Check out our open positions. 📚 See on-demand content in our Knowledge Center. 📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
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