Bästa Rqm podcaster (2024)

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Live! #78 – Behind the Scenes with BSI Head of IVD Notified Body, Alex Laan 57:26

6d ago57:26

57:26

This show was recorded 25 April 2024. We encourage you to download the IVDR timeline presented at the beginning of this session by ⁠⁠completing the form on this page⁠⁠. Please join us live for future shows and ask your own questions! We hold one RQM+ Live! panel discussion per month and you can sign up at the ⁠⁠⁠Knowledge Center⁠⁠⁠ or ⁠⁠⁠Events⁠⁠⁠ …

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FDA Releases Final Rule on Laboratory-Developed Tests (LDTs): What You Need to Know | MedTech Voices 12:17

7d ago12:17

12:17

𝗡𝗘𝗪𝗦 → FDA releases final rule on Laboratory-Developed Tests (LDTs) 🚨 RQM+'s Bethany Knorr Chung, PhD, RAC and Margot Borgel, Ph.D. dive into the details of what you need to know, including: ✅ The 4-year phase-in timeline for compliance ✅ Expanded enforcement discretion for certain LDTs ✅ Grandfathering clause for currently marketed LDTs Watch now …

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Samantha Howard, Study Director (Jordi Labs) | Excellence Spotlight 11:47

8d ago11:47

11:47

Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 🔬 Hot on the heels of Jordi Labs' groundbreaking new publication support for simulated use testing of blood-contacting medical…

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Noel Keegan on Clinical Data Management | Excellence Spotlight Bonus 10:56

18d ago10:56

10:56

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 aspe…

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Nancy Morrison's Keys to Thriving in Regulatory Affairs: Lessons Learned from a 30+ Year Career 19:44

25d ago19:44

19:44

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. N…

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Live! #77 – Get Ahead of the Crisis: How Your Quality System Can Prevent Negative Impacts on Customers, Patients, and Reputation 55:26

27d ago55:26

55:26

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 a…

1
Sew-Wah-Tay, Vice President of Strategic Regulatory Affairs | Excellence Spotlight 14:50

1M ago14:50

14:50

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, …

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How does a notified body clinical reviewer approach a review? | MedTech Voices 13:06

1M ago13:06

13:06

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 facilit…

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Adam Eason, Senior Study Director (Jordi Labs) | Excellence Spotlight 10:30

1M ago10:30

10:30

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 Stu…

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Noel Keegan, Sr. Director, Data Operations (Clinical Trials) | Excellence Spotlight 10:46

2M ago10:46

10:46

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 with Noel Keegan, a central figure in RQM+ clinical trial services. Noel is Sr. D…

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Kaitlin Lerner, Director of Operations, Lab Services (Jordi Labs) | Excellence Spotlight 11:25

2M ago11:25

11:25

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. 🔬 Kaitlin Lerner is "that chemist" with a Gibbs free energy tattoo. As Director of Operations, she's also one of the most bril…

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Anastassia Young, Senior Consultant | Excellence Spotlight 11:04

2M ago11:04

11:04

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. Yesterday, we published a clip of RQM+ Senior Consultant Anastassia Young, MS discussing our recent conversation with the FDA …

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Streamlining AE Reporting in PMCF Studies (FDA Perspective) | MedTech Voices 8:45

2M ago8:45

8:45

Are you navigating adverse event (AE) reporting in post-market clinical follow-up (PMCF) studies? In a recent discussion with the FDA, we've uncovered valuable insights into exemptions and variances for AE reporting that could significantly reduce your reporting burden. This collaboration between RQM+ and the FDA paves the way for a more efficient …

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Live! #76 – MDCG 2023-7: New Clinical Evidence Pathways for Legacy and New Devices 59:28

2M ago59:28

59:28

This show was recorded 22 February 2024. We encourage you to download the supplemental PDF content for 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. Th…

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Song Seto, Principal, Regulatory and Quality Practice | Excellence Spotlight 9:28

2M ago9:28

9:28

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. 🌌 Meet the supremely talented Song Seto, PhD, RAC in our latest Excellence Spotlight interview. Song is a Principal in our RA/…

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The Expansion of AI in In Vitro Diagnostics | MedTech Voices 33:20

3M ago33:20

33:20

Summary This discussion provides a high-level overview of the current state of artificial intelligence (AI) in in vitro diagnostics (IVDs). The conversation between Director of IVD Intelligence and Innovation, Margot Borgel, and Principal Regulatory Scientist, Bethany Chung, Ph.D., RAC, covers several aspects of AI in IVDs, including its use in dia…

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Taryn Meade, Director of Biological Evaluation Consulting | Excellence Spotlight 13:16

3M ago13:16

13:16

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. 🔬 Meet RQM+ Director of Biological Evaluation Consulting, Taryn Meade, in our latest Excellence Spotlight interview! Jaishanka…

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An MDCG 2023-7 Summary (🎟️ RSVP for our Feb. 22 expert panel) | MedTech Voices 4:28

3M ago4:28

4:28

📢 Hear Jaishankar Kutty, Ph.D.'s four-minute summary on MDCG 2023-7 and how you can benefit from attending next week's RQM+ Live! panel discussion: New Clinical Evidence Pathways for Legacy and New Devices. 🎟️ RSVP for the 22 February event here. Why are we talking about this? To address and clarify potential misinterpretations of Article 61, Items…

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Insights on FDA Approval and Future Challenges for Transcatheter Tricuspid Valve Replacement Devices | MedTech Voices 14:08

3M ago14:08

14:08

🏥 In connection with the FDA’s recent approval of Edwards Lifesciences’ transcatheter tricuspid valve replacement device, here is some commentary from RQM+ Vice President of Intelligence & Innovation, Jaishankar Kutty, Ph.D., about the importance of the benefit-risk story within the target patient population under the aegis of the state of the art …

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Garrett Jeffries, Principal, Clinical and Post-Market Practice | Excellence Spotlight 13:59

3M ago13:59

13:59

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. From bioengineering student at the University of Pittsburgh to PMCF study leader, meet Garrett Jeffries, PhD in our newest Exc…

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Elizabeth Starling, Senior Consultant | Excellence Spotlight 12:48

3M ago12:48

12:48

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. 📜 Elizabeth Starling went from law school aspirations to becoming a force in regulatory affairs and clinical research as a Sen…

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EU MDR Expert Panel Feedback (#11) | MedTech Voices 14:32

3M ago14:32

14:32

💬 New MedTech Voices Episode: Sally Sennitt and Jaishankar Kutty, Ph.D. dissect the expert panel's review of a groundbreaking extravascular implantable cardiac defibrillator (ICD) and offer insights into regulatory challenges and cardiac care innovation. Takeaways: 👇 Expert Review Insights for a Novel Extravascular ICD: Get an insider's perspective…

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Laurie Pettit, Senior Manager, RA/QA Consulting Services | Excellence Spotlight 13:20

3M ago13:20

13:20

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. 🌟 A seasoned expert in global regulatory affairs and project management, Senior Manager Laurie Pettit, PMP shares her journey …

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What makes a good EU MDR program from a maintenance perspective? | MedTech Moments 10:15

3M ago10:15

10:15

MedTech Moments are a curated selection of the most impactful snippets from our expert panel discussions. This clip was taken from RQM+ Live! #72 – EU MDR Timelines and Fine Lines: Unraveling Critical Transition Nuances to Gain Compliance. What makes a good EU MDR program from a maintenance perspective? We answered this question in RQM+ Live! #72, …

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Nicholas Wilson, Principal, Clinical and Post-Market Practice | Excellence Spotlight 14:53

3M ago14:53

14:53

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. Meet Nicholas Wilson, Ph.D. – Principal, Clinical and Post-Market Practice – in our new Excellence Spotlight interview. What m…

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The Proposed Amendments to MDR and IVDR | MedTech Voices 14:47

3M ago14:47

14:47

Have you seen the proposed amendments to MDR and IVDR published this week? Margot Borgel, Ph.D. and Jaishankar Kutty, Ph.D. sat down to discuss the details of this proposal, the potential impacts to manufacturers, and some questions and concerns surrounding this proposal. All current transition timelines have been extended by 2.5 years with new dea…

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Live! #75 – Exiting PFAS: A Strategic Blueprint for Medical Device Manufacturers 1:24:02

4M ago1:24:02

1:24:02

This show was recorded 18 January 2024. Download the slides from this presentation (including bonus slides not presented) by submitting the form on this page. Please join us live for future shows and ask your own questions! We hold one RQM+ Live! panel discussion per month and you can sign up at the Knowledge Center or Events pages at RQMplus.com. …

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Alexia Haralambous, Senior Principal | Excellence Spotlight 14:30

4M ago14:30

14:30

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. 2️⃣ things we're excited about today... 1. Our new Excellence Spotlight interview featuring RQM+ Senior Principal and former F…

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Niki Caporali Spaniel, Principal, CPMP, Practice Manager | Excellence Spotlight 14:26

4M ago14:26

14:26

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. 🎆 Happy new year! We're bringing the most positive energy we can to start 2024 with a heartwarming and uplifting RQM+ Excellen…

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Lindsay Wright, Senior Consultant / Capability Manager | Excellence Spotlight 12:56

5M ago12:56

12:56

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 week's Excellence Spotlight shines on a standout member of our clinical and post-market team, Senior Consultant / Capab…

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Blood Pressure Control via Renal Denervation: Knowns vs. Unknowns | MedTech Voices 11:15

5M ago11:15

11:15

After a lull which has now picked up with FDA approvals, what's next for renal denervation? RQM+ VP of Intelligence and Innovation Jaishankar Kutty, Ph.D. shares the knowns and unknowns in a new video clip. 📝 Quick summary Renal denervation is a technology that aims to control blood pressure by disrupting renal nerve activity through a minimally in…

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Rostislav Stoykov, Principal RA/QA | Excellence Spotlight 14:59

5M ago14:59

14:59

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. ➕ Today's Excellence Spotlight features Principal RA/QA Rostislav Stoykov. With a strong foundation in biomedical and clinical…

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A PFAS Primer (🎟️ RSVP for our Jan. 18th expert panel) | MedTech Voices 8:57

5M ago8:57

8:57

🚨 Hear Jaishankar Kutty, Ph.D. discuss the critical impact of PFAS phase-out on medical device manufacturing and then, 🎟️ RSVP to our January 2024 event for exclusive downloadable content. We hope you find Jai's commentary to be an excellent summary of the topic! Our January presentation and panel, Exiting PFAS: A Strategic Blueprint for Medical De…

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Live! #74 – A New Era of LDT Oversight: Adapting to FDA Regulations 54:14

5M ago54:14

54:14

This show was recorded 30 November 2023 and can be viewed on our website ⁠⁠⁠⁠here⁠⁠⁠⁠. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Knowledge Center⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠. We have a ton of on-demand content there, too. Thank you for tuning in! 🙏 Takeaways LDTs have historically been s…

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Torrie DeGennaro, Principal | Excellence Spotlight 10:02

5M ago10:02

10:02

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. ➕ The plus is the people at RQM+ and today's Excellence Spotlight features Torrie DeGennaro, a star in biomedical engineering …

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Richard Freeman, Director of Global Audit Practice | Excellence Spotlight 13:57

5M ago13:57

13:57

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. ➕ Today's Excellence Spotlight proudly features our Director of Global Audit Practice, Dr. Richard Freeman. Richard's journey …

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Andrew Lakey, Senior Consultant | Excellence Spotlight 9:41

6M ago9:41

9:41

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. ➕ In today's 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁, we're extremely excited to feature Senior Consultant Andrew Lakey, Ph.D. Andrew is a multid…

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Brandy Chittester, Senior Director of Clinical Operations | Excellence Spotlight 10:05

6M ago10:05

10:05

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. 💬 "Stay ready so you don't have to get ready." – Brandy Chittester, Senior Director of Clinical Operations In a new Excellence…

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Hrishikesh Gadagkar, Senior Principal Engineer | Excellence Spotlight 14:59

6M ago14:59

14:59

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 proudly showcases the technical excellence personified by our team. Senior Principal Engine…

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EU MDR Expert Panel Feedback (#10) | MedTech Voices 14:59

6M ago14:59

14:59

🎥 Sally Sennitt and Jaishankar Kutty, Ph.D. are starting off this week with plenty of good things to say in a new MedTech Voices video. This time, they unpack the EU MDR expert panel's evaluation of a novel resorbable device aimed at revolutionizing hernia repair procedures. Why watch (or listen) 👇 🔍 Scrutinizing the Longevity of Resorbable Devices…

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Cari Kniola, Senior Director of Project Management | Excellence Spotlight 15:00

6M ago15:00

15:00

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. ➕ Meet Senior Director of Project Management Cari Kniola in our newest Excellence Spotlight interview 👇 Cari navigates clinica…

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Live! #73 – October Overview: Essential Insights from an Eventful Month in MedTech 1:02:43

6M ago1:02:43

1:02:43

This show was recorded 26 October 2023 and can be viewed on our website ⁠⁠⁠here⁠⁠⁠. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our ⁠⁠⁠⁠⁠⁠⁠⁠⁠Knowledge Center⁠⁠⁠⁠⁠⁠⁠⁠⁠. Thank you for tuning in! 🙏 Listen in as Boston Scientific's Sr. Global Regulatory Intelligence & Advocacy Manager join…

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Ethan Elshoff, Senior Project Manager | Excellence Spotlight 10:51

7M ago10:51

10:51

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 and host Jaishankar Kutty, Ph.D. are back this week with a feature on RQM+ Senior Project M…

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Catherine Kang, Principal Consultant | Excellence Spotlight 14:21

7M ago14:21

14:21

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. Today we're shining the spotlight on Principal Consultant Dr. Catherine Kang! We love this interview and hope you'll listen. W…

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EU MDR Expert Panel Feedback (#9) | MedTech Voices 14:59

7M ago14:59

14:59

🎥 Sally Sennitt and Jaishankar Kutty, Ph.D. are back and looking into the expert panel's insights on a shoulder replacement system; a device that has the potential to redefine orthopedic solutions. Why you should watch 👇 📘 Deep Understanding of Clinical Evidence: Dive into the intricacies of what constitutes 'sufficient' clinical data and why it's …

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Kevin Rowland, Director of R&D | Excellence Spotlight 9:49

7M ago9:49

9:49

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. Meet RQM+ Director of R&D (and "detective" 🕵️) Kevin Rowland in our new Excellence Spotlight... 🔍 Two highlights about Kevin..…

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Live! #72 – EU MDR Timelines and Fine Lines: Unraveling Critical Transition Nuances to Gain Compliance 59:25

7M ago59:25

59:25

This show was recorded 28 September 2023 and can be viewed on our website ⁠⁠here⁠⁠. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our ⁠⁠⁠⁠⁠⁠⁠⁠Knowledge Center⁠⁠⁠⁠⁠⁠⁠⁠. Thank you for tuning in! 🙏 The extension of the EU MDR compliance timeline offers a reprieve for medical device manufact…

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Diane Cox, Principal Consultant | Excellence Spotlight 8:21

7M ago8:21

8:21

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. 🌟 The plus is the people at RQM+ and our Excellence Spotlight series celebrates them... as well as the significant impact they…

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Live! #71 – Material Matters: Navigating Risks and Strategies for Improving Medical Device Safety 53:41

8M ago53:41

53:41

This show was recorded 21 September 2023 and can be viewed on our website ⁠here⁠. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our ⁠⁠⁠⁠⁠⁠⁠Knowledge Center⁠⁠⁠⁠⁠⁠⁠. Thank you for tuning in! 🙏 We all know: ensuring the safety and efficacy of medical devices is critical to protecting patien…

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EU MDR Expert Panel Feedback (#8) | MedTech Voices 9:18

8M ago9:18

9:18

🎥 We're starting off the week right with a NEW MedTech Voices 🚨 Join our Medical Director Sally Sennitt and VP of Intelligence and Innovation Jaishankar Kutty, Ph.D. as they dissect the expert panel review of a groundbreaking neurostimulator designed to treat focal epilepsy in adults. 🧠⚡ Why watch?🤔 1️⃣ Gain Insights into the Complexities of Regula…

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