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Day One Agenda
Tuesday, December 5

8:00   REGISTRATION & WELCOME COFFEE

8:50   CHAIRPERSON’S OPENING REMARKS

9:00   OPENING ICE-BREAKER: SHARING INSIGHTS ON KEY COMPONENTS TO ENSURE MEDICAL DEVICE POSTMARKET SURVEILLANCE QUALITY
This interactive ice breaker will open the event with an opportunity for all participants to move around the conference room with the goal of meeting other delegates and engaging in swift discussions. The audience is encouraged to briefly exchange perspectives with other supplier quality assurance executives in attendance. Participants in this warm-up session are also given the opportunity to directly build contacts.

9:45   KEYNOTE PANEL DISCUSSION: SURVEYING THE CONTINUED EVOLUTION OF THE POSTMARKET ROLE
• Evaluating status of global regulations and harmonization efforts
• Challenges associated with advancements in tools and automation
• Market influences impacting the continual evolution of the PMS role and responsibilities
MODERATOR:
Barry Sands, RQMIS
PANELISTS:
Clifton Hart, INTUITIVE SURGICAL
Lily Li, QUIDEL ORTHO
Stephanie Berger, PHILIPS

10:30   COFFEE & NETWORKING BREAK

11:00  FIRESIDE CHAT: NOTIFIED BODY PERSPECTIVE ON EU IVDR IMPLEMENTATION
As IVD medical device manufacturers continue to gain experience in achieving IVDR certification for new and legacy products and with the approach of the end of the transition period for class D devices in 2025, it is critical for postmarket executives to strive to explore more streamlined operations and processes to comply with all EU IVDR requirements. Essential to gaining complete compliance is all guidance is having a thorough comprehension of all regulatory expectations and this interview format will enable the audience to address specific questions to notified body experts providing clarity into concerns of critical and timely importance.
Marta Carnielli, Head of Certification IVD
TÜV SÜD

11:45   STREAMLINING OPERATIONAL READINESS TO COMPLY WITH EU MDR
• Gap analysis to determine areas of non-compliance
• Outlining processes for vigilance reporting
• Templates for required reporting document
• Transitioning from planning to implementation
• Instituting training regarding EU MDR guidance
Camilla Borrini, Associate Director, QARA PMO
ZIMMER BIOMET

12:30   LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES

1:30   LEGAL PERSPECTIVE: EXAMINATION AND CLARIFICATION OF NOTABLE FDA GUIDANCES
• Expiration of alternatives to UDI requirements
        » Applicable effects of expiration
        » Exception deadlines
• 21 CFR 803 specification of criteria of reportable events
• Postmarket expectations of cybersecurity in medical devices
Seth Mailhot, Partner
HUSCH BLACKWELL

2:15  ISO ESSENTIAL POSTMARKET PROCEDURES REVIEW AND EXPECTATIONS
• ISO/FDA harmonization implications on postmarket operations
• Key processes for application of risk assessment of medical devices
        » ISO 14791
        » ISO/TR 24791
• Ensuring effective postmarket QMS to comply with ISO 13485
• Creation of an appropriate PMS plan
Stephanie Berger, PMS EU MDR Lead
PHILIPS

3:00   COFFEE & NETWORKING BREAK

3:30   FRAMEWORK FOR DEVELOPING COMPREHENSIVE PERIODIC SAFETY UPDATE REPORTS (PSUR)
• Outlining and decoding PSUR requirements
        » Article 83,84, 96, 87, 88 and 89
        » Article 120 (3)
        » Annex III & Annex XIV
• Timelines considerations for development & submission
• PSUR considerations for legacy medical devices
Susana Hidalgo, Manager Post-Market Surveillance
ESTABLISHMENT LABS

4:15   PRACTICAL APPROACHES TO POSTMARKET PMCF DEVELOPMENT IN COMPLIANCE WITH EU MDR
• Highlighting the importance of PMCF plans for certifications
• Overcoming challenges of PMCF study data collection
• Avenues and methodologies for PMCF study data collection
        » Registries
        » Surveys
• Increasing expectations of PMCF studies
Diptha Ramaswamy, Medical Writing and Clinical Post Market Surveillance Senior Manager
ZIMMER BIOMET

5:00   Closing Remarks & End of Day 1

Day Two Agenda
Wednesday, December 6

9:00   REGISTRATION & WELCOME COFFEE

9:20   CHAIRPERSON’S OPENING REMARKS

9:30-11:00   RISK-BASED FRAMEWORKS FOR STRENGTHENED POSTMARKET OPERATIONS
• Methodologies to identify and assess risks
         » Initial identification
         » Continued monitoring
• Alignment of risk thresholds with intended use and risk class
• Regulatory expectations related to benefit and risks
• Deciphering common pitfalls of risk evaluations

9:30   CASE STUDY ONE:
Nicky Kranz, Director of Quality – Risk Management
PHILIPS

10:15   CASE STUDY TWO:   ROBUST PRODUCT PERFORMANCE MONITORING & TRENDING
• Comprehensive, continuously-improving complaint & QMS data monitoring process
• Incorporating risk management expectations and IMDRF codes into monitors & thresholds
• EU MDR Article 88 Trend Reporting requirements & automating MIR similar incident calculations
• Strategies for use of data science, statistics, analytic tools, automation & AI
• Practical methods to detect signals and trends in various product types, lifecycle phases & datasets
Leah Featherstone, Sr Quality Systems Program Manager, Data Intelligence
MEDTRONIC

11:00   COFFEE & NETWORKING BREAK

11:30   PANEL: ENSURING MEDICAL DEVICE QUALITY DESPITE EVOLVING POSTMARKET SURVEILLANCE EMPLOYMENT TRENDS
• Industry factors impacting employment and retention trends
• Identifying key areas for potential knowledge growth
• Strategies to ensure continued education in postmarket roles
MODERATOR:
Barry Sands, RQMIS
PANELISTS:
Elizabeth Sandy, BD
Diptha Ramaswamy, ZIMMER BIOMET
Kandis Lattimore, BD
Nicky Kranz, PHILIPS

12:15   LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES

1:15   TOOLS AND PROCESSES IMPERATIVE FOR COMPREHENSIVE COMPLAINT & ADVERSE EVENT REPORTING FROM PUBLISHED POST MARKET LITERATURE
• Development of key operational frameworks for systematic literature review
• Performing thorough gap analyses to deter failures and proactive actions
• Emphasizing proactive monitoring considerations
• Standardization of data despite variations in collection
• Impact of AI and digital capabilities on data analytics
Queenita Fernandes, Sr. Medical Safety Manager
MEDTRONIC

2:00   LEGAL PERSPECTIVE: DECODING CURRENT AUDIT AND ENFORCEMENT TRENDS
• Assessing the current warning letter issuance landscape
• Usage of traditional vs. non-traditional enforcement tools
• Highlighting enforcement attention areas during audits
• Factors impacting audit, regulatory and inspection trends
Lina Kontos, Partner
HOGAN LOVELLS

2:45   Closing Remarks & Conference Conclusion