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Virtual

9th Annual

MEDICAL DEVICE POSTMARKET SURVEILLANCE CONFERENCE

September 16-17, 2025 | Virtual Event

9th Annual

MEDICAL DEVICE POSTMARKET SURVEILLANCE CONFERENCE

September 16-17, 2025
Virtual Event

Ensuring Stringent Postmarket Monitoring through Thorough Complaint Monitoring Strategies, Streamlined Data Management and a Comprehensive Understanding of Global Quality Expectations

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Day 1 Agenda
Day 2 Agenda
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Distinguished Presenters Include:

Camilla Borrini

Associate Director, QARA PMO
ZIMMERBIOMET

Abeda Habtemariam

FDA Partner
ARNOLD & PORTER

Paula Searcy

Senior Director, PMCF Strategy
CLINQURE

Christopher Brodrick

Senior Product Reviewer, Orthopedic Devices SME
GMED NORTH AMERICA

Vishal Joshi

Senior Manager, Quality Engineering
BD

Deepthi Badarinath

Senior Regulatory
FLUXERGY

Philip Desjardins

Partner
ARNOLD & PORTER

Seth Mailhot

Partner
BARNES & THORNBURG

Scott D. Danzis

Partner
COVINGTON & BURLING

Plarent Ymeri

Founder and CEO
SMARTEEVA

Monica R. Chmielewski

Partner
FOLEY & LARDNER LLP

Olumide Opeke

Medical Safety Manager
QUIDELORTHO

Ronak Dunung

Senior Manager
PHILIPS

Kandis Lattimore

Quality Manager, Post Market Surveillance
BD

Jessica Ringel

Partner, FDA and Life Sciences
KING AND SPALDING

Linda Braddon

President & CEO
SECURE BIOMED EVALUATIONS

Get to Know Our Key Speakers:

Monica Chmielewski, Foley & Lardner LLP

Monica R. Chmielewski is a health care and life sciences lawyer solely focused on the representation of health care providers, pharmaceutical, biotech and medical device companies, and pharmacies in life sciences law, health care, health care transactions, clinical research, supply chain, and food and drug law. She has experience assisting clients with regards to all aspects of medical research, development and commercialization, including regarding the regulation and conduct of clinical trials and decentralized clinical trials, FDA submissions and pharmaceutical and medical device manufacturing, licensing and commercialization assistance. She is a partner and vice chair of the firm’s Health Care Practice Group.

Philip Desjardins, Arnold & Porter

Philip Desjardins, Partner in Arnold & Porter’s Life Sciences & Healthcare Regulatory Practice, brings two decades of experience working with the U.S. Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH) and serving in pivotal leadership roles in Johnson & Johnson’s MedTech businesses. During his time at Johnson & Johnson, Phil held leadership roles in the company’s Orthopedic, Diabetes, and Cardiovascular and Specialty Solutions groups. As head of CDRH’s policy organization, Phil developed the agency’s policies governing medical devices in relation to legislation, regulations, and enforcement actions.

Camilla Borrini, Zimmer Biomet

Camilla is Associate Director of Quality and Regulatory Affairs PMO at Zimmer Biomet, where she leads cross-functional teams and large-scale strategic initiatives to ensure compliance with the European Medical Device Regulation (MDR).

She holds a Master’s degree in Biology and Healthcare Management, which provides a strong scientific and organizational foundation for her work. With over a decade of experience in the medical device industry, Camilla has played a key role in transforming regulatory complexity into operational excellence.

A Special Thanks to Our Sponsors

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Agenda – Day One

Tuesday, September 16

9:55   CHAIRPERSON’S OPENING REMARKS
10:00-11:15   SESSION SERIES: RISK MANAGEMENT, POST-MARKET SURVEILLANCE, AND CLINICAL EVALUATION
• Approaches to conducting a benefit-risk assessment
• Determining if a recall is needed and evaluating a strategy
• Best practices for documenting the benefit-risk assessment
10:00   PART ONE

Vishal Joshi, Senior Manager, Quality Engineering
BD LIFE SCIENCES
Olumide Opeke, Medical Safety Manager
QUIDELORTHO
Linda Braddon, President & CEO
SECURE BIOMED EVALUATIONS

10:45   PART TWO

Deepthi Badarinath, Senior Regulatory
FLUXERGY

11:15    ARTIFICIAL INTELLIGENCE-BASED TOOLS AND USES FOR POST-MARKET SURVEILLANCE AND VIGILANCE

• Data analysis and pattern recognition considerations
• Predictive analytics and risk assessment of AI
• Automated report generation and early warning systems
• Real-time monitoring and active reportability monitoring
• Literature search, analysis, and algorithmic bias mitigation

Plarent Ymeri, Founder and CEO
SMARTEEVA

12:00   COFFEE & NETWORKING BREAK
12:30   LEVERAGING TECHNOLOGY TO ENHANCE POST-MARKET SURVEILLANCE STRATEGY
• Leverage tech to streamline operations and provide visibility
» Data collection and analysis
» Reporting and compliance
» Enhancing safety
» Regulatory considerations
• Defining the regulatory and quality system requirements
• Identifying the data sources of PMS and how to create actionable insights

Kandis Lattimore, Quality Manager, Post Market Surveillance
BD

1:00   FDA’S LEGAL AUTHORITY AND ENFORCEMENT ACTIONS IN THE POST MARKET ARENA
• FDA legal authority for post-market compliance
• Recent trends and recent FDA enforcement
» Warning letters
» Consent decrees
» Quality system enforcement
• Promotion enforcement
» Future direction for enforcement

Scott D. Danzis, Partner
COVINGTON & BURLING
Linda Braddon, President & CEO
SECURE BIOMED EVALUATIONS

1:45   COFFEE & NETWORKING BREAK
2:15   PANEL DISCUSSION: EMERGING POST-MARKET SURVEILLANCE TRENDS IN FDA MEDICAL DEVICE ENFORCEMENT
• Increasing utilization of “non-traditional” enforcement tools for PMS
• Assessing the change in administration and what it means for the FDA
• Cybersecurity management and AI-enabled devices for PMS
• FDA’s PMS system for electronic health records and claims data
• FDA’s addressing of global harmonization and regulatory trends in PMS

Monica R. Chmielewski, Partner
Foley & Lardner LLP
Abeda Habtemariam, FDA Partner
ARNOLD & PORTER

3:00   FDA AND POST-MARKET OPERATIONS: METHODS TO STREAMLINE COMPLIANCE
• Understanding PMS requirements for the U.S.
• FDA classification & risk assessment
• FDA clinical data requirements
• Strategies to streamline documentation for compliance

Jessica Ringel, Partner, FDA and Life Sciences
KING AND SPALDING

3:45   CLOSING REMARKS AND END DAY ONE

Agenda – Day Two

Wednesday, September 17

9:55   CHAIRPERSON’S OPENING REMARKS
10:00   CONSIDERATIONS FOR ARTIFICIAL INTELLIGENCE SOFTWARE IN POST-MARKET SURVEILLANCE
• Assessing the various levels of implementation and integration
• Use of AI to categorize complaints for data analytics
• Leveraging automated processes in regulated environments
• Considering new technologies to detect quality issues

Philip Desjardins, Partner
ARNOLD & PORTER

10:45   NAVIGATING NOTIFIED BODY EXPECTATIONS: PROCEDURES AND SOLUTIONS FOR MANUFACTURERS
• Assessing the current EU MDR compliance landscape
• Notified bodies’ expectations and practical steps for direction
• Strategies for manufacturers to communicate with notified bodies
• Notified body perspectives on EU IVDR implementation
• PSUR preparation, notified bodies’ expectations, and feedback

Camilla Borrini, Associate Director, QARA PMO
ZIMMERBIOMET

11:30   COFFEE & NETWORKING BREAK
12:00  CYBERSECURITY INITIATIVES IN SECURING PRODUCT QUALITY
• Manufacturers addressing security failures relating to PMS
• Cybersecurity intersecting with quality and what it means for PMS
• Valuing collaboration between cybersecurity and PMS teams
• Gauging trends in cybersecurity product marketing initiatives
• Regulatory concerns surrounding post-market cybersecurity

Seth Mailhot, Partner
BARNES & THORNBURG

12:45    RISK MANAGEMENT AND A HOLISTIC APPROACH TO HARMONIZING DATA ACROSS THE QMS
• Addressing challenges in interpreting and integrating data across multiple processes
• Identifying commonalities in data sets to sharpen focus on safety and performance
• Designing a QMS framework that enables holistic data sharing across all processes
• Demonstrating ROI to executive leadership to drive stronger data collection and review practices

Ronak Dunung, Senior Manager
PHILIPS

1:30   COFFEE & NETWORKING BREAK
2:00   PANEL DISCUSSION: IMPLEMENTATION STRATEGIES FOR ALIGNING WITH EU MDR EXPECTATIONS
• Execution of the EU MDR four risk classes of medical devices
• EU MDR clinical data requirements on clinical evidence
• Execution of Periodic Safety Update Reports (PSURs)
• Execution of Post-Market Clinical Follow-up (PMCF) studies

Kandis Lattimore, Quality Manager, Post Market Surveillance
BD
Plarent Ymeri, Founder and CEO
SMARTEEVA

2:45   PMCF OPTIONS FOR LEGACY DEVICES
• Overview of EU regulations and MDCG guidance
• Special routes available for legacy devices
• Well-Established Technologies (WET) considerations
• General and specific PMCF methods for legacy devices

Christopher Brodrick, Senior Product Reviewer, Orthopedic Devices SME
GMED NORTH AMERICA

3:30   POST-MARKET CLINICAL FOLLOW-UP (PMCF): BEST PRACTICES FOR ENSURING SAFETY AND EFFICACY OF DEVICES

• Assessing the requirements for developing a PMCF Plan
• Guidance to PMCF under the MDR 2017/745
• Strategies to quickly meet PMCF regulatory requirements
• Common mistakes to PMCF and best practices for resolutions
• Enhancing trust in the MD lifecycle through post-market activities
• Documentation and considerations to PMCF clinical investigations

Paula Searcy, Senior Director, PMCF Strategy
CLINQURE

4:15   CLOSING REMARKS AND END DAY TWO

Previous Attendees Include:

Sr. Manufacturing Quality Engineer, ABIOMED
Product Surveillance Supervisor, ARTHREX INC
VP, Regulatory Affairs and Quality Assurance, ARTHREX INC
Senior Manager, Global Post Market, AVANOS MEDICAL
Manager, Complaints & Vigilance, BAYER HEALTHCARE
Clinical Compliance Lead, BAYER HEALTHCARE
Senior Clinical Compliance Specialist, BAYER HEALTHCARE
Sr. Quality Engineer, BAYLIS MEDICAL
Global VP, Clinical & Regulatory Affairs, BIONESS INC
Director, Quality Complaint Handling Unit, CONVATEC
Partner, COVINGTON AND BURLING
Sr. Manager, Quality, EDWARDS LIFESCIENCES
VP, Product Safety Quality – Global Quality, EDWARDS LIFESCIENCES
Mgr., International Quality Compliance, EDWARDS LIFESCIENCES
Post Market Surveillance Supervisor, ESTABLISHMENT LABS
Partner, HUSCH BLACKWELL
Sr Advisor, IDNs, INTERSYSTEMS
Sr. Post Market Surveillance Quality Analyst, INTUITIVE SURGICAL
EU Regulatory Postmarket Surveillance Lead, INTUITIVE SURGICAL
Senior Director Global Medical Device Safety, NOVOCURE
Director, Regulatory & Clinical Affairs, ORTHO DEVELOPMENT
Postmarket Surveillance Manager, PENUMBRA
Postmarket Surveillance Supervisor, PENUMBRA
Sr. Director, Postmarket Surveillance, PHILIPS
Manager – Risk Management, PHILIPS
Vice President Regulatory & Clinical Affairs, PROFOUND MEDICAL
Post-Market Surveillance Manager, SILK ROAD MEDICAL
Post Market Surveillance, TELEFLEX
Quality Lead, TERUMO MEDICAL
Sr. Dir., Global Reg Affairs, Clinical & Compliance, THERMO FISHER
Senior Director Strategic Business Development, TUV SUD
Product Safety & Stability Engineering Mgr  ULTRADENT PRODUCTS
Associate Director Quality Assurance, ZIMMER BIOMET

and many more

Who should attend:

Executives working within medical device corporations that will find this program of greatest relevance are those currently working to maintain compliance with product regulations in the US, and anticipating implementation of new FDA and global regulations, as well as ensuring accurate reporting of adverse events. Job titles of those executives that will find this program to be most applicable to the job function include:
• Post-Market Surveillance
• Complaint Handling
• Quality & Compliance
• Quality Surveillance
• Regulatory Compliance