RQM+ is a global MedTech service provider focused on accelerating compliance and market success. Through our unparalleled expertise and industry knowledge, we deliver specialized solutions and expedite the journey along the full product lifecycle for Med Device and IVD companies, from concept to commercialization to post-market.

Our portfolio of services enables the delivery of end-to-end solutions across the complete med device product lifecycle, with our: 
• Regulatory and Quality Consulting
• Lab Services (Jordi Labs)
• Clinical Trials
• Reimbursement
• Technology Solutions


RQM+

Join us for a free webinar on the importance and application of Real-World-Evidence (RWE) as we aim to help MedTech teams go from ideal frameworks to practical realities.

Get clear on the difference between real-world data (RWD) and RWE, including how raw data becomes fit-for-purpose evidence. Learn why RWE matters for decision making and regulatory success, and how to bridge the gap by putting it into practice! You’ll see how traditional and innovative data sources, from surveys and wearables to EHR datasets and claims databases, fit into putting RWE into practice.

We'll share real-life case studies and examples, as well as addresses common pitfalls to avoid, including data quality, device identification, follow-up, continuity of care, clinician insight, reporting consistency, and establishing clinical causality.

In the end, attendees will leave with clear practical tips and strategies for implementing real-world evidence in their own operations.

**Who Should Attend**

• Regulatory Professionals

• Clinical Affairs Professionals

• Product and Program Managers

• Health Economics and Reimbursement Professionals

• Post-Market Surveillance and Safety Managers

**Learning Objectives**

• How real-world evidence can support medical devices

• Current methods of acquiring real-world data and their strengths and weaknesses

• Case study highlighting successful use of real-world evidence to support PMCF

**Presenters**

• Bethany Chung, PhD, RAC, Director of Technical Solutions and Innovation, RQM+

• Amelia Hufford, PhD, SVP, Clinical and Regulatory Science Operations, 3Aware

A certificate of attendance is available upon request for live attendees.


Bridging the Real-World Evidence Gap

**Electric Brains & Regulatory Pains: Accelerate Neurology Innovation, Slash Risk, & Win Approval**

Neurological devices are rapidly advancing, from AI-driven diagnostics and brain-computer interfaces (BCIs) to transformative implantable therapies for conditions such as Parkinson’s, epilepsy, and paralysis.

But the path to commercialization involves complex regulatory challenges, clinical trial requirements, and unique ethical considerations. This is especially true as innovations increasingly blend hardware with AI-driven software to bridge biological and artificial neural networks.

🧠 *So… how do you bring a neurological device to market with losing your mind? (or your regulatory approval)*

Join RQM+ experts for an actionable and insightful panel session where you will learn how to:

*   **Identify High-Potential Innovations:** Pinpoint neurological technologies primed for rapid market uptake, including the critical interplay between hardware and AI-based software devices.
*   **Simplify Regulatory Complexity:** Clearly navigate FDA and EU MDR requirements, ensuring compliance without unnecessary delays.
*   **Manage Ethical and Data Privacy Risks:** Tackle head-on the ethical considerations specific to neural devices, including AI integrations and biological data handling.
*   **Win Clinical Approval:** Deploy strategic clinical trial designs and leverage Real-World Evidence (RWE) effectively, ensuring faster and smoother market entry.

This session delivers practical insights to help your organization successfully commercialize innovative neurological products.

**Who Should Attend:**

*   Regulatory affairs professionals
*   Clinical trial managers and coordinators
*   Product development leaders and engineers
*   Quality assurance specialists
*   Executives and decision-makers responsible for innovation and commercialization outcomes

**Learning Objectives:**

*   Understand key innovations, especially at the intersection of biological and artificial neural networks.
*   Gain clear strategies to streamline FDA and EU regulatory pathways.
*   Identify and mitigate ethical and data privacy challenges unique to neurotechnologies.
*   Learn actionable methods to design and execute successful neurological clinical trials.

**Panelists:**

*   Allison Komiyama, Ph.D., RAC – Vice President, MedTech Innovations
*   Bethany Chung, Ph.D., RAC – Senior Manager, Technical
*   Christine Santagate, RAC – Vice President, Lab Services

**Moderator:**

*   Jon Gimbel, Ph.D. – Vice President, Technical

**RQM+ certification of attendance available upon request for live attendees.**


RQM+ Live! #88 — Electric Brains & Regulatory Pains: Accelerate Neurology Innovation, Slash Risk, & Win Approval

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 Attend?**

*   **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 Attend?**

*   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)

*Certificate of Participation available upon request for live attendees.*


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

*While this session will definitely provide value on its own, we encourage you to *[*watch part one on demand*](/rsvp-live-85-medical-device-cybersecurity)* before joining this panel discussion.*

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 FDA 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+

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.

*Certificate of Participation available upon request for live attendees.*


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

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 will 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: 

*   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 attend: Regulatory, quality, clinical, legal, and product leaders responsible for EU market access for medical devices and IVDs. 

Panelists and moderator: 

*   Greg Griffin, BSI 
*   Claire Burrows, Brabners 
*   Chris Parr, RQM+ 
*   Jaishankar Kutty, RQM+ 

A certificate of attendance is available upon request for live attendees.


RQM+ Live! #89 – Compliance for EU Market Access: An actionable panel featuring BSI, Brabners, and RQM+

Speakers

Claire Burrows

Regulatory Partner, Brabners

Greg Griffin, PhD, MRSE

Technical Specialist, BSI

Chris Parr, PMP

Principal, RQM+

Jaishankar (Jai) Kutty, Ph.D.

Vice President of Regulatory Affairs, Reimbursement, & Market Access, RQM+ (Moderator)

Replays

Bridging the Real-World Evidence Gap

RQM+ Live! #88 — Electric Brains & Regulatory Pains: Accelerate Neurology Innovation, Slash Risk, & Win Approval