Chicago, USA

3rd American MedTech – Medical Safety & Compliance

The world's greatest minds in medical device safety, regulatory compliance and emerging technologies and coming together to discuss the future of MedTech.

KEY INFORMATION

Millennium Knickerbocker Hotel, 163 East Walton Place, Chicago, USA

April 1-2, 2026

09:00 - 17:30 Local Time

Part of the Pharmacovigilance World Tour

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80+

participants

20+

speakers

days

10+

hours of networking

15+

roundtable discussions

What to expect

For two packed days, you’ll be immersed in the latest trends, challenges, and game-changing ideas. Over 40 industry experts will share their insights, real-world experiences, and inspiring visions. Whether you’re deep into strategy or focused on the nitty-gritty of regulations, there’s something for everyone.

It’s not just about listening; it’s about connecting. Network with like-minded professionals, share your experiences, and together, let’s shape the future of medical devices. Come to Chicago and be part of a community that’s passionate about making a difference.

EXPERT INSIGHTS FROM INDUSTRY LEADERS

Learn directly from top medical device companies driving excellence in safety, quality, and regulatory compliance. Discover how they implement robust processes, mitigate risks, and ensure consistent product safety across complex portfolios.

FUTURE-PROOF YOUR SAFETY AND COMPLIANCE

Stay ahead with sessions on AI-driven compliance monitoring, risk mitigation strategies, and continuous quality improvement processes designed to strengthen safety, ensure regulatory adherence, and maintain high-quality medical devices

SOLVE YOUR MOST PRESSING CHALLENGES

Participate in hands-on discussions, case studies, and panels focused on mitigating safety risks, ensuring regulatory adherence, and optimizing quality processes across complex medical device portfolios.

EXPAND YOUR NETWORK

Connect with regulatory leaders, quality assurance heads, compliance experts, and digital health innovators who are driving safer, more reliable medical devices

Conference format

This 2-day summit is dedicated to tackling today’s most critical challenges in MedTech safety, compliance, and quality—from regulatory complexity and product safety risks to quality bottlenecks and cross-functional coordination. Designed for senior compliance, quality, and regulatory leaders, the event combines strategic insight with practical, actionable solutions.

Visionary Keynotes

Best Practice Case Studies

Expert Panel Discussions

Interactive Workshops and Roundtables

Networking For Lasting Business Friendship

Fun and Icebreaking social events every evening

Day 1

STATE OF MEDTECH SAFETY: 2026 LANDSCAPE & EXECUTIVE PRIORITIES

Focus Areas:

Strategic Imperatives for Safety Leaders in 2026

Regulatory Momentum: FDA, MDR, and Global Post-Market Controls

Post-Market Excellence & Vigilance Evolution

Global Regulatory Divergence and Reporting Complexities

Workforce Future-Proofing & AI-Driven Safety Tools

Complaint Handling, CAPA Effectiveness, and Regulatory Updates

Day 2

ADVANCING MEDTECH SAFETY, COMPLIANCE, AND QUALITY IN THE DIGITAL ERA

Focus Areas:

Innovation, Digitalization, and AI in Safety & Compliance

Regulatory Momentum and Compliance Expectations

Digitalization of Safety Systems and PMS Workflows

Artificial Intelligence and Machine Learning Applications

Global Safety Data Sharing & Real-World Evidence Integration

Strategic Imperatives & Prioritization for Safety Leaders

EVENT speakers

Aparna Ahuja

Divisional Vice President Medical, Clinical and Scientific Affairs ID Rapid Diagnostics

Abbott

Richard Matt

Principle Consultant

Aspen Medical Risk Consulting

Mike Xie

VP of Quality and Regulatory Affairs

Sol-Millennium Medical Group

Subhadip Jana

Sr. Director, Global Regulatory Affairs

ADC Therapeutics

Edward Chekan

Vice President of Medical Affairs & Professional Education

Asensus Surgical

Humberto Valbuena

Director, Medical Affairs - US & LATAM

Alcon

Ras Viswanadha

Associate Director of Research (Biological Safety)

Zimmer Biomet

Leo Park

Sr. Director of Cyber Security

Click Therapeutics

Event HIGHLIGHTS

Visionary Keynotes

In-Depth Panels

Strategic Roundtables

Case Studies

Workshops

Networking

Key takeaways

STRATEGIC IMPERATIVES FOR SAFETY LEADERS IN 2026

End-to-end safety visibility, data integrity, inspection readiness, and safety-first culture.

REGULATORY MOMENTUM: FDA, MDR, AND GLOBAL POST-MARKET CONTROLs

Compliance expectations, vigilance reporting, and evolving regulatory frameworks.

DRIVING INNOVATION AND AI IN MEDTECH SAFETY & COMPLIANCE

Explore how emerging technologies, digital systems, and AI can enhance safety, compliance, and quality management across medical device operations.

POST-MARKET EXCELLENCE & VIGILANCE EVOLUTION

Active and predictive post-market surveillance, regulatory alignment, and accountability for safety leaders.

GLOBAL REGULATORY DIVERGENCE AND REPORTING COMPLEXITIES

Multi-regional vigilance, field safety actions, and harmonization vs. Localization.

WORKFORCE FUTURE-PROOFING & AI-DRIVEN SAFETY TOOLS

Upskilling, cross-functional adaptability, and automation of adverse event detection.

COMPLAINT HANDLING, CAPA EFFECTIVENESS, AND REGULATORY UPDATES

Enhancing complaint triage, CAPA measurement, and aligning with FDA & ISO 10993-1 changes.

Everything you need to know about This event in one spot.

Check out our event overview and agenda and discover 3rd American MedTech – Medical Safety & Compliance

PAST AND PRESENT

Our valued partners

TESTIMONIALS

I joined the conference in Spring 2023 and really enjoyed it. The program covered several topics of direct relevance to my daily activities, while also giving me perspectives on ‘macro trends’ of the medical devices industry. Speakers were experts and participants motivated to interact between sessions.

Rated 5 out of 5

Benjamin Rochette

Vice President, Global Regulatory Affairs, Coloplast

Great open dialogue in an expert community. Many valuable presentations, panel discussions and time for networking to share best practices and different views on similar challenges. Warm atmosphere to grow as team over two fabulous days. Also excellently organized and moderated by the WHY SUMMITS TEAM. Happy to join next year as well!

Rated 5 out of 5

Arite Wildau

Director Patient Safety, BIOTRONIK

I found the sessions were well organized, with an interesting mix of attendees from across the industry. Various key topics were covered, all pertinent to the current MedTech landscape with good discussions on common challenges and sharing of useful lessons, practical applications and future proofing strategies.

Rated 5 out of 5

Surinder Dhillon

Head of Commercial PMO, International, Hologic

Last week I had the opportunity to share my experiences and learn from industry experts at Why Summits MedTech Summit. It was an incredible experience!

Rated 5 out of 5

Sarah Paro

Global QMS Associate Director

I had the opportunity to offer participants insight on how to positively impact others’ well-being and influence organizational outcomes by viewing resilience, grit, and growth mindset as their leadership superpower! The dialogue afterwards was inspiring.

Rated 5 out of 5

Karen Forsha

Ph.D., Sr. Manager, Quality Systems, Terumo

“Always Be curious”

Who should attend?

Roles Invited:

C-Level Executives: Chief Safety Officer (CSO), Chief Compliance Officer (CCO), Chief Quality Officer (CQO)
- R&D Safety Strategy & Operational Excellence VPs, Global Heads, and Senior Directors of:
  - Safety & Compliance
  - Quality Assurance & Risk Management
  - Regulatory Affairs
  - Pharmacovigilance / Post-Market Surveillance
  - Clinical Safety & Medical Affairs
  - Enterprise Risk & Governance Excellence

Event partners

PREMIUM GOLD SPONSOR

Flinn.ai offers AI-powered software solutions to automate and streamline post-market surveillance (PMS) processes, including AI-assisted literature evaluation, automated vigilance database monitoring, automated monitoring of standards, regulations, and guidances, and AI-driven complaint and customer feedback categorization.

GOLD SPONSOR

At Alwis Group, we’re pioneering AI-driven solutions for the healthcare and pharmaceutical industries. Our innovative tools are transforming pharmacovigilance, enhancing drug safety monitoring, and streamlining regulatory compliance. Our suite of products includes:

ReTrans Enterprise: AI-powered literature surveillance

ReTrans Extension: Browser plugin for real-time safety data analysis

ScoMed: Intelligent medical literature scoring * ZiNex: Advanced medical document processing

ZiQuel: AI-driven quality complaint management

ZiTrack: Smart inbound receipt management

We’re committed to improving patient safety and operational efficiency through cutting-edge technology. Our solutions reduce costs, minimize errors, and accelerate processes, allowing healthcare professionals to focus on what matters most – patient care.

Event registration

$ 2349

Access to all conference sessions
Access to all networking activities during the conference
Conference materials
Coffee breaks with snacks and refreshments
Networking lunch

$ 3049

Access to all conference sessions
Access to all networking activities during the conference
Conference materials
Coffee breaks with snacks and refreshments
Networking lunch

Present on the Main Stage
Hold an exhibit at this event
Showcase your Brand in Marketing Material
Gain exposure through alternative partnership benefits

Position Your Brand Where the MEDTECH INDUSTRY Take Shape.

Get in front of the teams that manage pharma’s biggest programs. Explore sponsorship and exhibition opportunities at 3rd American MedTech – Medical Safety & Compliance.

Our Past Sponsors

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