Bölümler
-
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. 🙏
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 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+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.
-
This 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 duringPanelists:
Taryn Meade – Director of Biological Evaluation Stephen Bond – Senior Toxicologist Amanda DeGraw, MS, Ph.D., DABT – Principal ToxicologistModerator:
Christine Santagate, RAC – Vice President of Lab ServicesTopics 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.
-
Eksik bölüm mü var?
-
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.
🌟 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.
-
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 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.
-
*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.
-
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 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.
-
*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 populationsThese 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.
--
📲 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.
-
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. 🙏
Join us for an exclusive panel discussion featuring top experts from TÜV SÜD, GMED, and BSI as they dive into the intricacies of structured dialogue between MedTech manufacturers and notified bodies. As regulatory expectations continue to evolve under MDR and IVDR, these dialogues are vital for ensuring compliance and expediting market access.
Our panelists will provide valuable insights into key topics such as:
Effective strategies for engaging with notified bodies in structured dialogues Managing device classifications, submission processes, and project timelines How to navigate changes in notified bodies and maintain compliance Best practices for developing regulatory plans in new technology areasThis session is ideal for regulatory professionals, quality assurance teams, and MedTech manufacturers seeking practical guidance on optimizing their interactions with notified bodies.
Don't miss this opportunity to learn from leading voices in the industry and gain actionable strategies to ensure regulatory success. This session will be invaluable for anyone navigating MDR/IVDR compliance.
Panelists:
Alex Laan – Head of the IVD Notified Body, BSI Dr. Andreas Stange – Senior Vice President MHS Regulatory & Quality, TÜV SÜD Tom Patten – IVDR/IVD International Manager, GMEDModerator:
Jaishankar (Jai) Kutty, Ph.D. – Vice President, Global Regulatory Affairs, RQM+--
📲 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.
-
*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 manufacturersWhether 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!
--
📲 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.
-
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 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 interview with Principal Consultant, Christine Anderson, RAC.
Learn how Christine's journey from microbiology to becoming an 𝗮𝗹𝗹-𝗿𝗼𝘂𝗻𝗱 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝘀𝗽𝗲𝗰𝗶𝗮𝗹𝗶𝘀𝘁 has shaped her into a genuine leader in the field.
Christine shares:
✔️ Her transition from R&D to regulatory affairs
✔️ The importance of thorough background research and curiosity in regulatory work
✔️ Her approach to building long-term client relationships
✔️ The rewards of helping clients
✔️ How diverse client interactions continually broaden her expertise
We hope you enjoy this conversation and stay tuned as we highlight more of our RA/QA experts in the coming weeks! 🌟
--
📲 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.
-
*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 reviewThese 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!
--
📲 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.
-
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 run of 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 interviews with our Jordi Labs, an RQM+ Company team members continues with Christine Santagate, RAC chatting with Senior Chemist II and supervisor of our gas and liquid chromatography teams, Michael Louis, Ph. D.
Listen in to hear how Mike became a 𝗿𝗲𝘀𝗽𝗲𝗰𝘁𝗲𝗱 𝗹𝗲𝗮𝗱𝗲𝗿 𝗮𝗻𝗱 𝗺𝗲𝗻𝘁𝗼𝗿, known for his extensive chemistry expertise and collaborative approach. 👨🔬
In the interview Mike shares:
✔️ His journey from University of Massachusetts Amherst to University of New Hampshire, and finally, to Jordi Labs, an RQM+ Company
✔️ The excitement of working with cutting-edge instrumentation to solve complex problems
✔️ His experience developing methods for detecting fluorinated compounds at ultra-low levels
✔️ How management support enables innovative problem-solving
✔️ Valuable advice for newcomers to the industry
--
📲 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.
-
*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.*
🚨 Watch our newest video to learn best practices for 𝗮𝗱𝘃𝗲𝗿𝘀𝗲 𝗲𝘃𝗲𝗻𝘁 𝗿𝗲𝗽𝗼𝗿𝘁𝗶𝗻𝗴 𝗶𝗻 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹𝘀.
Manager of Safety Management Melanie Miller reveals:
📊 AE definitions for medical devices vs. drugs
🌍 Global reporting requirements and timelines
📋 Minimum data set for reportable AEs
🔬 Reporting differences across study types
Elevate your clinical trial expertise with RQM+ (this is the 21st video in our clinical trials-specific video series this year) and ensure regulatory compliance.
Reminder that you can find all of our clinical trial videos in other places, too. 👇
💼 LinkedIn
📺 The RQM+ YouTube channel
📧 For support with clinical trials, please contact us directly.
--
📲 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.
-
*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 𝗰𝗿𝗶𝘁𝗶𝗰𝗮𝗹 𝗮𝘀𝗽𝗲𝗰𝘁𝘀 𝗼𝗳 𝗲𝗳𝗳𝗲𝗰𝘁𝗶𝘃𝗲 𝗮𝗻𝗱 𝗲𝗳𝗳𝗶𝗰𝗶𝗲𝗻𝘁 𝘀𝗮𝗳𝗲𝘁𝘆 𝗺𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗶𝗻 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹𝘀.
Melanie covers:
📋 Key components of effective safety management
🔬 Pre-enrollment planning and study protocol design
📊 Importance of comprehensive safety management plan
💻 Leveraging digital-first mindsets and automation
🤝 Breaking down silos for improved communication
🎓 Ongoing training and education for all stakeholders
🔄 Continuous improvement in safety processes
𝗬𝗼𝘂'𝗹𝗹 𝗹𝗲𝗮𝗿𝗻 𝗮𝗯𝗼𝘂𝘁 𝘁𝗵𝗲 𝗹𝗮𝘁𝗲𝘀𝘁 𝘁𝗿𝗲𝗻𝗱𝘀 𝗶𝗻 𝘀𝗮𝗳𝗲𝘁𝘆 𝗺𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁, 𝘁𝗼𝗼, 𝗶𝗻𝗰𝗹𝘂𝗱𝗶𝗻𝗴:
🤖 AI and machine learning in safety data analysis
📱 Digital health technologies for real-time patient reporting
👥 The roles of key players in the safety management process
There's a lot here! Effective safety management is crucial for maintaining data integrity, ensuring regulatory compliance, and most importantly, safeguarding patient well-being throughout the clinical trial process.
Reminder that you can find all of our clinical trial videos in other places, too. 👇
💼 LinkedIn
📺 The RQM+ YouTube channel
📧 For support with clinical trials, please contact us directly.
--
📲 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.
-
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. 🙏
The recently published Regulation (EU) 2024/1860 amends the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) by introducing some significant changes that will impact manufacturers and the entire MedTech industry.
One of the changes is the introduction of a requirement for manufacturers to inform national competent authorities in cases of supply chain interruptions, or the withdrawal from the market, of certain critical medical devices and IVDs.
Join our expert panel to explore the implications of these new obligations for manufacturers and learn actionable strategies to ensure compliance.
In this comprehensive discussion, our regulatory and quality experts will cover:
Impact Assessment: An overview of the amendments, including changes to transition timelines for IVDR and the phased rollout of EUDAMED. Supply Chain Management: Insights into the new obligation for manufacturers to provide advanced notice of supply chain interruptions and strategies to ensure a robust and resilient supply chain. Industry Perspectives: An examination of feedback from industry stakeholders and how companies are preparing for these regulatory changes. Compliance Strategies: Guidance on meeting the new requirements, including implementation within your Quality Management System (QMS). Quality and Regulatory Support: How RQM+ can support your company with regulatory change assessments, EUDAMED data management, and the implementation of new supply chain notification processes.By attending this event, you will gain a clear understanding of the amendments to MDR and IVDR and learn practical steps and strategies to achieve compliance. Register now to stay ahead of these critical regulatory changes and ensure the continued success of your products in the European market.
Panelists and moderator:
Erik Vollebregt – Advocaat, Axon Science Based Lawyers Heike Moehlig-Zuttermeister – Global Director In-Vitro Diagnostics, TÜV SÜD Donielle Johnson – Global Regulatory Affairs Executive Ed Ball – Manager, Intelligence & Strategic Execution, RQM+ Amie Smirthwaite, Ph.D. – Senior Vice President, Scientific Affairs, RQM+ (moderator)Certificate of Participation available upon request for live attendees.
Who Should Attend: This panel discussion is ideal for regulatory affairs professionals, operations management, quality assurance professionals, production planning and supply chain managers, and MedTech manufacturers navigating the amended IVDR and MDR requirements.
--
📲 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.
-
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 interview series continues as Christine Santagate, RAC chats with Dr. Anthony Grice, a leading chemist at Jordi Labs for over a decade!
Discover how "Ant" became our go-to 𝗖𝗦𝗜 𝗼𝗳 𝗖𝗵𝗲𝗺𝗶𝘀𝘁𝗿𝘆 🕵️♂️, solving complex problems with creativity. Ant shares:
✔️ His journey from the UK to becoming a polymer chemistry expert
✔️ The excitement of tackling diverse challenges in analytical chemistry
✔️ His experience with GPC and its applications in #medicaldevices
🔨 Some unconventional methods used to solve client problems (sledgehammer, anyone?)
✔️ Valuable advice for aspiring chemists and regulatory professionals
From deformulating golf balls to smashing solar panels, we hope Ant's interview inspires you and showcases the problem-solving ingenuity of RQM+/Jordi Labs staff.
--
📲 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.
-
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 interview series continues this week, as Christine Santagate, RAC is joined by Lab Coordinator Craig Young of the Jordi Labs team.
👨🔬 Discover how Craig's diverse background in chemistry and project management led him to become an 𝗲𝘀𝘀𝗲𝗻𝘁𝗶𝗮𝗹 𝗽𝗮𝗿𝘁 𝗼𝗳 𝗼𝘂𝗿 𝗼𝗽𝗲𝗿𝗮𝘁𝗶𝗼𝗻𝘀.
Craig shares:
✔️ His journey from WPI to Las Vegas and back to Mansfield
✔️ Experiences in biodiesel production and laboratory startups
✔️ How his "jack-of-all-trades" nature suits lab coordination
✔️ His role in implementing ClickUp for project management
✔️ Valuable advice for those entering the scientific industry
⚗️ We'll be continuing to highlight more Jordi Labs all-star team members in the coming weeks, so stay tuned.
--
📲 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.
-
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 interview series continues this week, as Christine Santagate, RAC is joined by Chemist II Michael Morales of the Jordi Labs team.
👨🔬 Discover how Michael's passion for chemistry led him to becoming a 𝘁𝗿𝘂𝗲 𝗲𝘅𝗽𝗲𝗿𝘁 𝗶𝗻 𝗴𝗮𝘀 𝗰𝗵𝗿𝗼𝗺𝗮𝘁𝗼𝗴𝗿𝗮𝗽𝗵𝘆.
Michael shares:
✔️ His journey through academia and into industry
✔️ The importance of perseverance in scientific research
✔️ His experience in tackling complex projects and method development
✔️ The rewards of mentoring and giving back to the scientific community
✔️ Valuable advice for those considering a career in chemistry
🔬 Check out the interview to learn from Michael's expertise and hopefully be inspired by his enthusiasm for analytical chemistry as well!
We plan to continue to highlight many more all-star employees from Jordi Labs in the coming weeks, so stay tuned.
--
📲 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.
-
*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 𝗰𝗿𝗶𝘁𝗶𝗰𝗮𝗹 𝗿𝗼𝗹𝗲 𝗼𝗳 𝗖𝗥𝗢𝘀 𝗶𝗻 𝗱𝗮𝘁𝗮 𝗺𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁.
Noel covers:
🤝 The importance of partnership between CROs and sponsors
🏆 Key performance and quality indicators across all trial phases
🔍 Independent quality review processes
📚 Leveraging standardized libraries and best practices
🎯 Tailoring services to meet specific sponsor needs
In the end, a CRO should act as an extension of the sponsor's team, providing expertise, accountability, and flexibility throughout the clinical trial process.
Reminder that you can find all of our clinical trial videos in other places, too. 👇
💼 LinkedIn
📺 The RQM+ YouTube channel
📧 For support with clinical trials, please contact us directly.
--
📲 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.
-
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 short interview series continues this week, as Christine Santagate, RAC is joined by another member of the Jordi Labs team, Tommy Kumlin.
See how Tommy's background in chemistry and chemical engineering led him to become a jack-of-all-trades in analytical techniques. 🔬
Tommy shares:
✔️ His specialization in spectroscopy, microscopy, and thermal analysis
✔️ How he combines different techniques for comprehensive analysis
✔️ The satisfaction of instrument troubleshooting and maintenance
✔️ The importance of collaboration in a professional environment
✔️ Valuable advice for those entering the industry
Stay tuned as we plan to highlight additional Jordi Labs staff in the coming weeks! 🧫
--
📲 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.
- Daha fazla göster
