Making MedTech Happen with RQM+

This panel was recorded October 2, 2025.⁠⁠⁠⁠ We hope you'll join us live in the future to ask your own questions and participate in the attendee chat! See similar events on demand and read other free MedTech resources at ⁠⁠RQMplus.com⁠⁠.

PMCF surveys can strengthen your CER and PSUR or create rework. In this 60-minute panel with live audience Q&A, RQM+ leaders from regulatory, clinical, and scientific writing share what MDR reviewers look for and how to design surveys that generate decision-grade evidence. The session is intended for regulatory affairs, post-market surveillance, clinical evidence, and medical writing leaders at MedTech manufacturers.

Listen to learn how to: 

• Define clear objectives, endpoints, and target population so the survey maps to your PMCF plan and CER. 
• Improve response rates without bias and capture higher-quality data, including adverse events and usability feedback. 
• Learn how to position your physician level survey as a chart review. 
• Document methods, rationales, and traceability so notified bodies can follow the logic. 
• Avoid the top reasons reviewers push back on PMCF surveys and how to correct them. 

Walk away with a practical checklist to pressure test your next PMCF survey and reduce review risk. 

Who should attend: 

• Regulatory affairs leaders and PMS managers. 
• Clinical evidence and clinical operations leads. 
• Scientific and medical writing leaders, including CER and PSUR authors. 
• Quality leaders responsible for post market surveillance programs. 

Panelists and moderator: 

• Torrie DeGennaro – Vice President, Scientific & Medical Writing 
• Bethany Chung, Ph.D., RAC – Director, Technical Solutions & Innovation 
• Garrett Jeffries, Ph.D. – Principal 
• Jon Gimbel, Ph.D. – Vice President, Regulatory Affairs

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This panel was recorded September 18, 2025.⁠⁠⁠⁠ We hope you'll join us live in the future to ask your own questions and participate in the attendee chat! See similar events on demand and read other free MedTech resources at ⁠RQMplus.com⁠.

Manufacturers often focus on MDR or IVDR and miss cross-cutting EU laws that impact CE marking, technical documentation, quality systems, and reporting. As a result, devices may be delayed, blocked from the market, or recalled, and manufacturers may suffer legal penalties and reputational harm.

In this RQM+ Live! panel discussion, experts from BSI, Brabners, and RQM+ map how sectoral, horizontal, and national requirements fit together, how notified bodies assess them, and how to build an evidence-based path to EU market access.

We cover practical implications of recent and emerging regulations, including:

• Batteries Regulation (EU) 2023/1542
• AI Act (EU) 2024/1689
• Packaging and Packaging Waste Regulation (EU) 2025/40
• European Health Data Space Regulation (EU) 2025/327

You’ll learn:

• About the market surveillance regulation (EU) 2019/1020 and EU Blue Guide.
• How to identify all applicable legislation for your product and verify coverage.
• What notified bodies expect to see and the typical level of scrutiny.
• How to structure your compliance register, QMS updates, and regulatory reporting.
• Transition timelines and planning tactics to avoid last-minute surprises.

Who should listen: Regulatory, quality, clinical, legal, and product leaders responsible for EU market access for medical devices and IVDs.

Panelists and moderator:

• Greg Griffin, PhD, MRSE – Technical Specialist, BSI
• Claire Burrows – Regulatory Partner, Brabners
• Chris Parr, PMP – Principal, RQM+
• Jaishankar Kutty, PhD – Vice President of Regulatory Affairs, Reimbursement, & Market Access, RQM+ (Moderator)

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This panel was recorded June 26, 2025.⁠⁠⁠⁠ We hope you'll join us live in the future to ask your own questions and participate in the attendee chat! See similar events on demand and read other free MedTech resources at RQMplus.com.

Summary

Hear leading neurology innovators discuss how to navigate complex regulatory pathways, accelerate approvals, and reduce risk in bringing groundbreaking neurological devices to market.

LinkedIn panelist and moderator profiles 

• 🧠 Allison Komiyama, Ph.D., RAC – Vice President, MedTech Innovation
• 🧠 Bethany Knorr Chung, Ph.D., RAC – Senior Manager, Technical
• 🧠 Christine Santagate, RAC – Vice President, Lab Services
• 🧠 Jon Gimbel, Ph.D. – Vice President, Technical (moderator)

Timestamps

00:00 Introduction to Neurology Innovation and Regulatory Challenges
02:57 Panelist Introductions and Their Expertise
05:54 Exciting Developments in Neurological Devices
08:48 The Role of AI and Machine Learning in Neurology
11:58 Testing and Safety Considerations for Neurological Devices
14:51 Regulatory Framework and Challenges for Neurological Devices
19:00 Ethical Considerations in Neurological Device Development
35:20 Ethical Considerations in Medical Devices
36:47 Patient Information and Healthcare Provider Communication
39:03 Regulatory Perspectives on Device Usability
42:57 Challenges in Medical Device Studies
46:58 Real World Evidence in Medical Device Evaluation
51:10 Navigating Regulatory Pathways: FDA vs. EU
55:55 The Future of Medical Device Regulation
01:01:30 Exciting Innovations in Neurological Treatments
01:06:49 Concluding Thoughts on Clinical Trials and Future Directions

More neurology resources from RQM+

• Wires to AI: The Regulatory Landscape of Neurological Devices
• Artificial Neural Network Supporting Biological Neural Networks
• What is the Benefit of Seeing the Brain?

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This panel was recorded 20 March 2025.⁠⁠⁠ Please join us live in the future and have your own questions answered! You can sign up for these events and see other resources in the⁠ Knowledge Center⁠ at RQMplus.com.

Women’s health is finally getting the attention it deserves, yet progress is still slowed by gaps in clinical trial diversity, complex regulatory pathways, and funding challenges.

In this RQM+ Live! panel discussion, industry leaders and regulatory experts will share real-world strategies MedTech companies can use to navigate these barriers and bring life-changing innovations to market.

Why listen:

• Unlock Market Opportunities – Women’s health is one of the fastest-growing MedTech sectors, with rising investor interest and funding.
• Gain Regulatory Insights – Understand how evolving regulations impact clinical trials, approvals, and commercialization.
• Learn from Real-World Success – Hear how industry leaders are overcoming challenges and making an impact.
• Ask Your Toughest Questions – Engage directly with panelists during the live Q&A.
• Bring Innovations to Market – Get expert insights on bridging clinical research, regulatory approval, and commercialization.

Discussion topics:

• The Business Case for Women’s Health Innovation – Why investors, manufacturers, and regulators are prioritizing this space and what it means for MedTech companies.
• Clinical Trials and Data Gaps – The urgent need for inclusive research, historical data biases, and evolving regulatory expectations.
• Regulatory and Market Access Hurdles – Key challenges in securing approval and reimbursement—and how to overcome them.
• Scaling Women’s Health Solutions – Lessons from industry leaders on funding, partnerships, and commercialization strategies.

Who should listen:

• MedTech professionals driving innovation in women’s health
• Regulatory and quality leaders navigating complex approval pathways
• Clinical trial specialists improving diversity and data accuracy
• Investors and strategists seeking insights into funding and market growth
• R&D and product development teams designing women’s health solutions
• Healthcare policymakers and advocates shaping the future of women’s health innovation
  

Panelists and moderator:

• Marissa Fayer – CEO, Her Health Equity & DeepLook Medical
• Megan Callanan – US & Global Regulatory Lead, Natural Cycles
• Stephanie Kladakis – Executive Vice President, Chief Technology and Regulatory Officer, AgNovos Bioscience
• Alexia Haralambous – Senior Principal, RQM+
• Jaishankar (Jai) Kutty, Ph.D. – Vice President, Global Regulatory Affairs, RQM+ (moderator)

Chapters:

00:00 Introduction to Women's Health in MedTech

10:09 The Surge in Women's Health Innovation

20:08 Regulatory Challenges in Women's Health

29:52 The Business Case for Women's Health Innovation

33:54 Bridging the Gender Gap in Clinical Trials

37:02 Enhancing Diversity in Clinical Trial Recruitment

40:08 Understanding Regulatory Misconceptions in Women's Health

44:09 Strategic Partnerships for Market Access

56:03 Future Directions for Women's Health Innovation

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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.

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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.

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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.

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This is an experiment and AI-generated audio version of edition #51 of our weekly LinkedIn newsletter, the ⁠⁠⁠RQM+ Weekly Watch⁠⁠⁠.

This summary is automatically generated and should not be considered a direct statement from RQM+. While we strive for accuracy, please know this summary may contain errors. It's also only a brief snapshot of the material from this week's LinkedIn newsletter, which contains much more information.

A new edition of the RQM+ Weekly Watch is published on LinkedIn every Tuesday.

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This is an experiment and AI-generated audio version of edition #48 of our weekly LinkedIn newsletter, the ⁠⁠RQM+ Weekly Watch⁠⁠.

This summary is automatically generated and should not be considered a direct statement from RQM+. While we strive for accuracy, please know this summary may contain errors. It's also only a brief snapshot of the material from this week's LinkedIn newsletter, which contains much more information.

For the complete picture, please see the full newsletter ⁠⁠here⁠⁠. A new edition is published to LinkedIn every Tuesday.

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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.

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