9th Edition US MEDICAL DEVICE & DIAGNOSTIC POST-MARKET SURVEILLANCE, VIGILANCE & CLINICAL EVIDENCE CONFERENCE
Boston | 2026
Shaping the future of Post-Market Surveillance through strategy, compliance, and real-world insight
key information
- Boston, US
- 24th – 26th March 2026
Conference Insights
Gain practical, regulator-ready insights on building robust PMS systems. Explore global requirements (FDA, EU MDR, EUDAMED), PMCF integration, AI-driven surveillance, and real-world data use—turning post-market insights into improved safety, compliance, and lifecycle value
What to Expect:
- Practical, regulator-ready guidance on FDA, EU MDR, IVDR, MHRA, IMDRF and EUDAMED
- Real-world case studies from manufacturers, notified bodies, and regulators
- Actionable sessions on PMCF integration, signal detection, and complaint trending
- Insights into AI, digital health, and predictive PMS frameworks
- Interactive panels and roundtables tackling current industry challenges
- High-value networking with senior PMS, quality, regulatory, and safety leaders
Join for expert perspectives. Walk away equipped with practical frameworks, future-ready approaches, and meaningful industry relationships that strengthen post market surveillance, improve safety outcomes, and support confident regulatory decision-making
3 DAYS OF REAL-WORLD PMS
INSIGHTS & INNOVATION
PRE-CONFERENCE WORKSHOP DAY
INTERACTIVE WORKSHOPS
WORKSHOP A:
- Risk-based PMCF strategy
- Multi-source data integration
- Data-driven decision making
WORKSHOP B:
- Surveillance vs. endpoint-driven design
- Survey analytics & interpretation
- Driving design and lifecycle improvements
WORKSHOP C:
- Trend analysis & early risk detection
- Closing the feedback loop
- Building patient, clinician & regulator trust
DAY 1
STRATEGY & REGULATIONS
PMS Data & Insights Integration
- Data storytelling
- Cross-functional collaboration
Continuous improvement
AI, SaMD & Predictive PMS
- Software & AI/ML devices
- Predictive analytics
- Risk mitigatio
Global Regulatory Alignment
- FDA vs. EU MDR
- Cross-market PMS processes
- Proactive safety managemen
DAY 2
VIGILANCE
Signal Management & Clinical Relevance
- Safety signal management
- Clinical relevance assessment
- Corrective & preventive actions
Communication & Stakeholder Engagement
- Transparency & trust
- Clinician & patient communication
- Two-way feedback loop
PMS Optimization & Future-Readiness
- Resource management & scaling
- Technology & automation
- Value-driven evidence strategy
Our Industry Specialists
Sharon Perez
Adam Kleinman
Melissa Pieplow
Romiya G. Barry
Matthew Christensen
Colleen Watson
Theresa Mussaw
Shahzaib Rai
Chris Brodrick
Jansen Yuenger
Lucia Ureche
Kandis Lattimore
Taylor Dieringer
Dr. Queenita Fernandes
Aalap Patel
Christina Villar
Jennifer Saylor
Paul Mlynarczyk
Sandeep Shenoy
Abhinavdutt Singh
Shailee Rasania
WHY TAKE PART
- Cut through signal noise and focus on clinically meaningful risks that truly impact patient safety and regulatory decisions
- Gain practical, real-world strategies for signal detection, escalation, and CAPA from experienced PMS leaders
- Learn how to scale PMS programs effectively despite resource and budget constraints
- Stay ahead of global regulatory expectations across FDA, EU MDR, IVDR, MHRA, and emerging frameworks
- Understand how AI, automation, and real-world data are transforming PMS from compliance to value creation
- Improve communication with clinicians and patients to build trust, transparency, and stronger feedback loops
- Future-proof your PMS strategy by aligning clinical evidence, digital health, and post-market data
- Engage directly with peers and experts through panels, roundtables, and networking discussions
KEY TAKEAWAYS
Clinical relevance over signal volume
Effective PMS prioritizes meaningful signals, not noise
PMS data must drive action
Strong escalation pathways turn insights into CAPA, FCA, and risk mitigation
Communication closes the loop
Transparent, timely dialogue with clinicians and patients builds trust and improves outcomes
Resource-smart PMS is possible
Technology, automation, and prioritization enable scalable programs
AI and RWE are accelerators
Advanced analytics transform PMS from reactive compliance to proactive risk management
Cross-functional alignment is critical
Value is created when PMS, clinical, quality, and regulatory teams work as one
Future-ready PMS delivers value
Integrated evidence strategies support safety, innovation, and lifecycle growth
Moments Captured
Take a glimpse into the highlights of our conferences, where ideas come to life and connections are made
Our Testimonials
This was one of the best conferences that I've attended in the last couple of years. The shorter workshop sessions on the pre-conference day led to wonderful interactions that fed into the remainder of the conference.
– Associate Director Clinical Compliance
A global community of professionals plays a vital role in ensuring that all regulated pharmacological drugs or medical devices meet the highest compliance standards for our loved ones.
– Manager, Field Manager
It was interesting to understand how the Post Market is managed in the district and the importance it has around the world. I was able to understand a little more about the regulation.
– Post Market Surveillance Specialist
This event provided valuable insight into other Medical Device manufacturer processes and emerging technologies to tackle a lot of the same problems my company faces. It also gave me a lot of opportunities to network and brainstorm with my peers.
– Corporate Quality Systems Director
This conference is a wonderful opportunity to dive deeper into the world of PMS and interact with those from similar fields.
– Regulatory Affairs Specialist
It was great! Varied Topics and experts! Great networking and agreeable peers!
– People Manager Field assurance
Excellent presentations and content - must attend
– Sr. Clinical Operations Manager
Wonderful networking and exchange of ideas for benchmarking
– Director, Quality
I gained valuable insights related to improving process efficiency using AI and appreciated the opportunities for open discussions and learning from others experiences in establishing and improving their PMS systems
– Product Quality Complaints Manager
The PMS conference including the workshop was information, collaborative and engaging.
– Senior Quality Engineer
YOUR ALL-IN-ONE GUIDE TO THE EVENT
Get the full scoop on what’s in store!
Explore the event overview and dive into the agenda for the 10TH EDITION EUROPEAN MEDICAL DEVICE CYBERSECURITY CONFERENCE 2026—your gateway to 3 days of strategy, science, and innovation.
COLLOCATE WITH US/EUROPE
- 20th - 22nd October 2026
- Boston, MA, US
You're In Good Company
