Device Advice by RQM+ - podcast cover

Device Advice by RQM+

RQM+ industry-leading experts and often special guests discuss regulatory, quality, clinical, lab, and reimbursement challenges MedTech companies are facing. RQM+ is the world's leading MedTech service provider offering consulting, clinical trial, lab, and reimbursement services, as well as technology solutions to support the entire product lifecycle. With more former FDA, Medicines, and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. Please visit RQMplus.com to learn more.

Episodes

Live! #87 – Built for Her: Funding, fixing, and fueling the next era of MedTech

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 strat...

Apr 08, 20251 hr 1 min

Breast Cancer Panel, Part 3: MedTech Innovations

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. -- 📲 ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Follow RQM+ on LinkedIn.⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ 📩 ⁠⁠⁠⁠Subscribe to the RQM+ Weekly Watch.⁠⁠⁠⁠ ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠💼 Check out our open positions.⁠⁠⁠⁠⁠⁠...

Apr 07, 202527 min

Breast Cancer Panel, Part 2: Treatment and Advocacy

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. -- 📲 ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Follow RQM+ on LinkedIn.⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ 📩 ⁠⁠⁠⁠Subscribe to the RQM+ Weekly Watch.⁠⁠⁠⁠ ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠💼 Check out our open positions.⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠...

Apr 05, 202533 min

Breast Cancer Panel, Part 1: Diagnosis and Personal Journeys

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. -- 📲 ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Follow RQM+ on LinkedIn.⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ 📩 ⁠⁠⁠Subscribe to the RQM+ Weekly Watch.⁠⁠⁠ ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠💼 Check out our open positions.⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠...

Apr 04, 202519 min

Weekly Watch #51 (AI-Generated, Subscribe On LinkedIn)

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 Link...

Apr 02, 202523 min

Weekly Watch #48 (AI-Generated, Subscribe On LinkedIn)

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 ⁠⁠her...

Mar 11, 202530 min

Celebrating the Women Who Inspire Us 💜

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. 🥺 RQM+ applauds ALL women who overcome challenges and inspire others every day. Happy International Women's Day. 💜 Special thanks to our remarkable storytellers: Lisa Sampson Melissa Orenstein Aditi Patel, MS RA LaTya Lindsay Samantha Howard Ashley Harger Jaishankar Kutty, Ph.D. -- 📲 ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Follow RQM+ on LinkedI...

Mar 10, 202513 min

Weekly Watch #47 (AI-Generated, Subscribe On LinkedIn)

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 ....

Mar 06, 202517 min

Live! #86 – PART 2: Medical Device Cybersecurity: Proven Strategies for Connected Devices and SaMD

⁠ 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...

Feb 12, 20251 hr 13 min

Live! #85 – Medical Device Cybersecurity: Proven Strategies for Connected Devices and SaMD

⁠ 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 cybers...

Dec 19, 20241 hr 3 min

Live! #84 – Critical Shifts in Biological Evaluation: Inside the New ISO 10993-1 Risk Management Framework

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 es...

Dec 05, 202458 min

Chris Parr, Principal Consultant | Excellence Spotlight

Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 🌟 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 frame...

Nov 14, 202413 min

Carrie Schneider, Principal Consultant | Excellence Spotlight

Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 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 ...

Nov 07, 202415 min

What makes a successful regulatory submission from a clinical trial perspective for IVDs? – MedTech CRO: Regulatory Expertise Series

*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...

Nov 04, 202410 min

Holly Cotter, Senior Consultant | Excellence Spotlight

Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 🧗‍♀️ 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'...

Oct 28, 202415 min

What makes a successful regulatory submission from a clinical trial perspective? (Part 3/3) – MedTech CRO: Regulatory Expertise Series

*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 S...

Oct 22, 202410 min

Live! #83 – Structured Dialogue: How to Engage with Notified Bodies

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 RQMpl...

Oct 17, 20241 hr 2 min

What makes a successful regulatory submission from a clinical trial perspective? (Part 2/3) – MedTech CRO: Regulatory Expertise Series

*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 (curren...

Oct 15, 20249 min

Christine Anderson, Principal Consultant | Excellence Spotlight

Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. ⭐ 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, Christi...

Oct 14, 202411 min

What makes a successful regulatory submission from a clinical trial perspective? (Part 1/3) – MedTech CRO: Regulatory Expertise Series

*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 Scient...

Oct 10, 202422 min

Michael Louis, Chemist II (Jordi Labs) | Excellence Spotlight

Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 🧪 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 i...

Oct 08, 20246 min

Best Practices In AE Reporting In Clinical Trials – MedTech CRO: Clinical Trial Execution Series

*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: 📊 A...

Oct 02, 202413 min

Effective and Efficient Safety Management In Clinical Trials – MedTech CRO: Clinical Trial Execution Series

*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 𝗲𝗳�...

Sep 26, 202411 min

Live! #82 – MDR and IVDR Amendments: Strategies for Supply Interruption Compliance

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....

Sep 26, 20241 hr 8 min

Anthony Grice, Chemist III (Jordi Labs) | Excellence Spotlight

Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 🧪 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 ...

Sep 25, 20248 min

Craig Young, Lab Coordinator (Jordi Labs) | Excellence Spotlight

Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 🧪 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 b...

Sep 16, 202411 min

Michael Morales, Chemist II (Jordi Labs) | Excellence Spotlight

Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 🧪 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 ...

Sep 12, 20248 min

How a CRO Helps with Data Management In Clinical Trials – MedTech CRO: Clinical Trial Execution Series

*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 𝗿�...

Sep 11, 202415 min

Tommy Kumlin, Chemist I (Jordi Labs) | Excellence Spotlight

Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 👨‍🔬 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 ...

Sep 04, 20247 min

Data Management In Clinical Trials (Maintenance/Closeout) – MedTech CRO: Clinical Trial Execution Series

*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.* 🎉 The data management party continues! Part 2 of our clinical trial data management series is here! Jaishankar Kutty, Ph.D. welcomes back Senior Director of Data Operations, Noel Keegan, to dive in...

Sep 03, 202414 min
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