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+

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.

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### **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

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

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 during this transition 

**Who Should Attend:** This session is essential for regulatory affairs professionals, quality managers, and R\&D teams involved in medical device development and biological safety assessment. Whether you're preparing for upcoming changes or seeking to optimize your current processes, this discussion will provide actionable insights for maintaining compliance and efficiency. 

**Panelists:**

*   Taryn Meade – Director of Biological Evaluation
*   Stephen Bond – Senior Toxicologist
*   Amanda DeGraw – Principal Toxicologist

**Moderator:** 

*   Christine Santagate – Vice President of Lab Services 

Register now to gain critical insights into these industry-shifting changes and ensure your organization is prepared for what the transcript reveals to be "one of the major changes in the standard" - the requirement to apply device risk management to biological evaluation. 

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


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

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 areas

This 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. Register today to secure your spot!

**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 - GMED

**Moderator:**

*   Jaishankar (Jai) Kutty, Ph.D. – Vice President, Global Regulatory Affairs, RQM+

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


RQM+ Live! #83 — Structured Dialogue: How to Engage with Notified Bodies

Speakers

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 - GMED

Jaishankar (Jai) Kutty

Vice President, Global Regulatory Affairs, RQM+

Replays

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

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