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2027 Agenda

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February 22nd

3:00 pm

REGISTRATION

3:30 pm - 4:20 pm WELCOME DAY SPECIAL CONTENT

Panel: Improving Supply Chain and Operational Performance Through Proven Cost Reduction Practices

Tamanna Prashar

Vice President, Global Supply Chain

Cepheid

Jeremy Padmos

Senior Vice President, Head of Diagnostics Supply Chain Management

Siemens Healthineers

Ravi Chandra

VP Strategic Planning & SC Transformation

Johnson & Johnson MedTech

Session Details Arrow Icon
  • Identifying the biggest cost drivers across manufacturing, sourcing, inventory and distribution—and focusing resources where they can have the greatest impact.
  • Using Lean, continuous improvement and process standardization to eliminate waste, improve productivity and reduce operational costs.
  • Balancing cost reduction with quality, service, safety and resilience, avoiding short-term savings that create downstream problems.
  • Optimizing manufacturing capacity, footprint and supplier networks to reduce structural costs while maintaining flexibility.
  • Building a culture of cost ownership where frontline teams and leaders continuously identify and act on opportunities to improve performance.
4:25 pm - 5:00 pm WELCOME DAY SPECIAL CONTENT

The Future of Medical Device Manufacturing and Operations Through Next-Generation Innovation and Production Strategies

Session Details Arrow Icon
  • Exploring how medical device manufacturing will evolve to meet future demands for efficiency, flexibility, and production capacity
  • Identifying emerging manufacturing technologies and innovations that will reshape production processes and operational performance
  • Leveraging AI and predictive analytics to enable smarter, more efficient manufacturing operations
  • Preparing manufacturing networks for future challenges through greater resilience, scalability, and adaptability
5:05 pm - 6:00 pm WELCOME DAY SPECIAL CONTENT

Panel: When Quality Fails: Managing Recalls, Shortages, Systemic Risk and Other Vulnerabilities

Robbie Roark

Global SVP Quality & Regulatory Affairs

Cordica Medical

Miguel Avila

Vice President, Global Quality and Regulatory Affairs

Cordis

Kevin Rooney

VP of Product Quality

Intuitive

Jose Lima

SVP, Head of Global Quality Operations

Philips

Iraida Garcia

Vice President of Global Quality

Terumo BCT

Session Details Arrow Icon
  • Root causes behind recent quality failures including process drift, supplier variability, and control breakdowns
  • How contamination events and recalls expose deeper fragility across interconnected supply networks
  • Addressing the compounding impact of quality issues on shortages, service levels, and patient access
  • Examining where quality systems break down between manufacturing, suppliers, and distribution
  • Why traditional compliance approaches are not enough to prevent repeat failures
  • Building proactive risk detection systems that identify issues before they escalate into recalls
  • Strengthening end-to-end quality ownership across manufacturing, supply chain, and regulatory functions
6:00 pm

Drinks Reception

6:30 pm

Executive dinner

(By Invite Only)

February 23rd

Stream 1 Chair

Dina Justice

Vice President, Regulatory Affairs

Terumo Medical Corporation

Stream 2 Co-Chair

Executive to be Announced

Medical Engineering Consultants

Stream 3 Co-Chair

Vishaka Rajaram

Sr. Director, Quality Strategy

Veeva MedTech

7:30 am - 8:15 am

registration & breakfast

8:15 am - 8:20 am

Opening Remarks & Important Announcements

8:20 am - 8:30 am

Chair’s Welcome Address

Dina Justice

Vice President, Regulatory Affairs

Terumo Medical Corporation

8:30 am - 9:05 am KEYNOTE

Supply Chain Reliability: Standardizing to Enable Flexibility

Dale Pease

Group VP, Supply Chain Operations, Orthopaedics

Stryker

9:10 am - 9:45 am Case Studies
Stream One - Manufacturing & Operations

Automation Starts with Optimization: Creating the Right Foundation Before Scaling Technology

Miguel Aldana

Sr. Vice President Global Supply Chain and Manufacturing

Siemens Healthineers

Session Details Arrow Icon
  • Understanding why process maturity must come before automation: How to identify whether operations are truly ready for technology investment and avoid automating inefficient processes
  • Building a strong operational foundation for scalable automation: Establishing standard work, process stability, and performance visibility before introducing advanced technologies
  • Identifying the right automation opportunities that deliver measurable business impact: Focusing investments on areas that improve quality, productivity, and operational resilience
  • Avoiding the hidden costs of automating complexity: Recognizing common mistakes that create more variables, inefficiencies, and maintenance challenges
  • Creating a balanced approach between technology and operational excellence: Aligning automation strategies with manufacturing goals, workforce capabilities, and continuous improvement efforts
Stream Two - Supply Chain

From Acquisition to Integration: Building a Unified and Resilient Medical Device Supply Chain

Keith Racine

Vice President ISC M&A and Integration

BD

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  • Proven strategies for aligning manufacturing, supply chain, and operations during every stage of M&A integration
  • Lessons learned from overcoming common integration challenges while maintaining business continuity and customer commitments.
  • Practical approaches to harmonizing processes, systems, and organizational cultures across newly combined businesses
  • Key priorities for the first 100 days to accelerate value realization and minimize operational disruption
  • Actionable frameworks for measuring integration success and building a resilient, scalable operating model for long-term growth
Stream Three - Quality & Regulatory Compliance

Design for Manufacturability: Embedding Quality, Reliability, and Patient Safety into Every Decision

Kelly Trott Drake

VP R&D Productivity Transformation

Medtronic

Session Details Arrow Icon
  • Moving quality from a downstream checkpoint to an upstream design philosophy
  • Building manufacturability, reliability, and patient safety into products from day one
  • The importance of asking the right questions, and asking them at the right stage of development
  • Breaking down functional silos between R&D, engineering, manufacturing, quality, and supply chain
  • Using design reviews, development gates, and cross-functional collaboration to reduce risk earlier
  • Balancing speed, innovation, regulatory expectations, and operational scalability
  • Lessons learned from implementing DFM practices across complex medical device portfolios
9:50 am - 10:25 am Workshops
STREAM 1 WORKSHOP

CI at Scale: Moving from Reactive Improvement to Built-In Performance in Manufacturing Networks

Executive to be Announced

MasterControl, Inc

Session Details Arrow Icon
  • Shifting Continuous Improvement from a reactive model driven by failures and KPI misses to a proactive system designed for continuous learning and prevention
  • Reframing recurring operational issues as signals of underlying system and network design gaps, rather than isolated site-level execution failures
  • Moving from local optimization to end-to-end network thinking, where performance outcomes are shaped by how processes, flows, and governance structures are designed
  • Elevating operational data from reporting output to structured feedback that informs system learning and decision-making
  • Building mature CI environments that continuously convert everyday operational signals into structural improvements in work design, governance, and operating models
STREAM 2 WORKSHOP

US FDA Inspections, QMSR, VIP, and MDSAP: Trends, Triggers, and Building Continuous Quality Readiness

Executive to be Announced

RQM+

Session Details Arrow Icon
  • What is driving FDA inspection trends today, including key triggers such as data integrity, CAPA effectiveness, supplier control, and post-market signals
  • How QMSR alignment with ISO 13485 is changing documentation expectations, audit readiness, and global regulatory harmonization
  • The role of FDA’s Voluntary Improvement Program (VIP) in shifting from reactive compliance to proactive, system-level quality improvement
  • What MDSAP audits consistently reveal about gaps in quality system maturity across manufacturing, suppliers, and global operations
  • How leading organizations are building continuous inspection readiness through real-time quality signals, risk-based monitoring, and integrated QMS visibility
STREAM 3 WORKSHOP

Multi-Year Road Mapping for Supply Chain Modernization and ROI

Executive to be Announced

Rockwell Automation

Session Details Arrow Icon
  • Outlining the strategic vision: modernize supply chain capabilities to drive resilience, agility, and measurable business impact
  • Prioritizing initiatives based on ROI and risk to target greatest efficiency, cost reduction, or service improvement
  • Developing a phased, multi-year roadmap balancing quick wins with foundational investments
  • Leveraging technology for end-to-end visibility and predictive insights to proactively manage disruptions and optimize performance
  • Ensuring executive sponsorship to align priorities, allocate resources, and maintain accountability
  • Addressing barriers: resistance to change, legacy systems, skills gaps, and interdependent processes
  • Embedding governance and CI mechanisms to track ROI, course-correct, and sustain long-term outcomes
10:25 am - 12:10 pm Pre-Arranged One-To-One Meetings Arrow Icon

These mutually agreed-upon conversations are arranged and facilitated by Executive Platforms staff to ensure attendees have valuable discussions about their top-of-mind questions, challenges, and opportunities.

  • 10:30 am – 10:50 am: Meeting Slot 1/Networking
  • 10:55 am – 11:15 am: Meeting Slot 2/Networking
  • 11:20 am – 11:40 am: Meeting Slot 3/Networking
  • 11:45 am – 12:05 pm: Meeting Slot 4/Networking
12:15 pm - 12:50 pm Case Studies
Stream One - Manufacturing & Operations

Advancing Operational Excellence Through Quality, Lean Processes, and Continuous Improvement -

Michael Cummane

Division VP Operations, Electrophysiology

Abbott

Session Details Arrow Icon
  • Applying Six Sigma and continuous improvement principles to strengthen manufacturing performance and operational efficiency
  • Embedding quality into operations to improve consistency, reliability, and execution across manufacturing environments
  • Identifying process inefficiencies and reducing variability to create more resilient and predictable operations
  • Engaging teams in a culture of accountability, problem-solving, and sustained operational improvement
Stream Two - Supply Chain

Building a Global Supply Chain from the Ground Up Through Strategic Network Design and Integration

Gaurav Goel

VP, Global Head of Supply Chain

Alcon

Session Details Arrow Icon
  • Establishing the foundations of an effective supply chain through strategic planning, infrastructure development, and operational alignment
  • Designing and optimizing supply chain networks to support global expansion, efficiency, and long-term growth
  • Navigating the complexities of transitioning from regional operations to an integrated global supply chain
  • Aligning manufacturing, distribution, logistics, and supplier networks to improve end-to-end visibility and performance
  • Creating a scalable and resilient global supply chain that can adapt to evolving market demands, regulatory requirements, and future growth
Stream Three - Quality & Regulatory Compliance

Enabling Successful Design and Manufacturing Transfers of Medical Devices

Raghu Jainapur

Vice President Quality

Minimed

Session Details Arrow Icon
  • Addressing real-world challenges and common pitfalls during design and manufacturing transfers, and effectively managing transfer milestones
  • Architecting and executing a quality and regulatory submission strategy · Translating design specifications into clear, actionable manufacturing instructions
  • Using pilot runs and iterative builds to identify and resolve manufacturability issues early
  • Aligning validation plans with real-world production conditions and conducting hands-on training
  • Building a structured knowledge transfer process to support smooth and scalable production scale-up
12:50 pm - 1:50 pm THEMED LUNCH DISCUSSIONS

Explore this year’s themed lunch discussions led by industry leaders, where executives engage in focused conversations over a meal, discussing topics they’re passionate about alongside their peers.

Regulatory Intelligence: Turning Inspection Data into Strategic Foresight

Andi Dell Collins

Executive Director, Supply Chain Practice

Assemble

Leading Enterprise-Wide Supply Chain Transformation with AI and Advanced Analytics

Executive to be Announced

ComplianceQuest

Closing the Gap between R&D and Manufacturing

Ruben Perez

Global Vice President, Supply Chain

Corza Medical

Advancing Operational Excellence and Driving Innovation in Medical Device Manufacturing

Graham Phillips

Chief Operating Officer

Endologix

The Anatomy of a Plant Shutdown: Managing Risk, Compliance, and Continuity While Reshaping the Global Manufacturing Network

Deep Krothapalli

Senior Director, Quality

Intuitive

The Governance Gap in Quality: Why Control Structures Are Failing Complex Manufacturing Networks

Executive to be Announced

Mission Plastics, Inc.

Smart Factories in MedTech: Hype vs. Operational Reality

Executive to be Announced

Rockwell Automation

Content to be Announced

Param Vig

SVP, Chief Information Security Officer

Solventum

1:55 pm - 2:30 pm KEYNOTE

Turning Manufacturing, Supply Chain and Quality into a Connected Performance Engine

Peter Bennett

SVP, Global Operations

Cardinal Health

Janna Parks

Senior Vice President, Global Quality, Regulatory & Medical Affairs

Cardinal Health

Session Details Arrow Icon
  • How Cardinal Health is connecting the three functions to improve reliability, quality, efficiency and customer service
  • Where the biggest opportunities exist at the intersections between manufacturing, supply chain and quality
  • How can leaders get teams to move beyond functional priorities and take ownership of outcomes across the wider operation?
  • How cross-functional teams are using shared data and visibility to identify risks earlier, uncover root causes across functions, and make faster, more informed decisions
  • What governance, metrics and ways of working are helping sustain that alignment
  • Practical examples and lessons from implementing a more connected approach, including how cross-functional decision-making has changed the way problems are identified and solved across a complex operating environment
2:35 pm - 3:10 pm Workshops
STREAM 1 WORKSHOP

From Co-Innovation to Impact: AI in Complaint Handling

Joe Goodman

CCO, Honeywell Technologies

Honeywell Life Sciences

Bart Reitter

VP Sales, Honeywell Technologies

Honeywell Life Sciences

Session Details Arrow Icon
  • Examine a recent AI co-innovation initiative undertaken with a global medical device manufacturer to support operational transformation for complaint handling
  • Explore how an established technology partnership can enable responsible AI adoption while balancing deployment speed, implementation risk, and quality management requirements
  • Discuss how life sciences expertise and customer process and product knowledge can be combined to deliver measurable operational and quality outcomes
STREAM 2 WORKSHOP

Building a Risk-Driven Audit Strategy: Managing Global Operations, Supplier Complexity, and the Gap in Audit Capability

Executive to be Announced

MDDAP, LLC

Session Details Arrow Icon
  • Examining current audit models and their limitations, where audits remain compliance-focused, retrospective, and weakly connected to operational risk and performance signals
  • Addressing the gap between global operational complexity and audit consistency, where multi-site manufacturing, diverse suppliers, and regional regulatory expectations create variable outcomes
  • Examining the growing mismatch between traditional audit approaches and modern product realities, including SaMD, AI-enabled devices, and cybersecurity requirements that demand deeper technical and lifecycle understanding
  • Addressing capability gaps in internal and supplier auditing, where auditor training often lags behind the complexity of technologies and systems being assessed, leading to inconsistent interpretation and risk evaluation
  • Learning how organizations are shifting toward risk-based, intelligence-led audit strategies, integrating data, supplier performance signals, and real-time operational insights to move from periodic compliance checks to continuous assurance
STREAM 3 WORKSHOP

Transforming Planning: Decision Intelligence, Process Orchestration, Data Visibility, and Embracing Uncertainty

Executive to be Announced

Fabriq

Session Details Arrow Icon
  • Redesigning planning as a decision-led operating model where choices are continuously optimized, not locked into static cycles
  • Connecting end-to-end planning processes through orchestration across demand, supply, and operations to enable coordinated execution
  • Establishing trusted, real-time data visibility as the backbone for faster, higher-confidence trade-off decisions
  • Embedding scenario-driven thinking to operationalize uncertainty rather than attempting to eliminate it from the system
  • Shifting from forecast accuracy as the goal to decision quality and speed as the primary measures of planning effectiveness
3:10 pm - 4:30 pm Pre-Arranged One-To-One Meetings Arrow Icon

These mutually agreed-upon conversations are arranged and facilitated by Executive Platforms staff to ensure attendees have valuable discussions about their top-of-mind questions, challenges, and opportunities.

  • 3:15 pm – 3:35 pm: Meeting Slot 5/Networking
  • 3:40 pm – 4:00 pm: Meeting Slot 6/Networking
  • 4:05 pm – 4:25 pm: Meeting Slot 7/Networking
4:35 pm - 5:35 pm PANEL

Risk as a Design Principle: Embedding Quality into Every Operational Decision

Steve C de Baca

Chief Patient Safety & Quality Officer

Philips

Session Details Arrow Icon
  • Reframing risk as a core input to enterprise strategy and execution, where decisions in product development, sourcing, and manufacturing are shaped by upfront risk understanding, not downstream correction or compliance response
  • Embedding risk intelligence into capital allocation, portfolio prioritization, and operational trade-offs, enabling leaders to explicitly weigh speed-to-market, cost efficiency, innovation ambition, and quality exposure in a structured way
  • Building an enterprise capability to convert fragmented signals from design, suppliers, manufacturing sites, and field performance into a single, decision-ready view of risk across the value chain, rather than siloed functional reporting
  • Establishing a unified enterprise risk language that aligns quality, supply chain, operations, regulatory, and commercial leadership, ensuring consistent interpretation of risk and eliminating localized or conflicting decision logic
  • Moving from periodic risk assessments to continuous, real-time risk governance, where live operational and supply chain data actively informs decisions, allowing the enterprise to anticipate disruption rather than react to it
5:40 pm - 5:55 pm

Chair’s Closing Remarks

Dina Justice

Vice President, Regulatory Affairs

Terumo Medical Corporation

6:15 pm

Drinks Reception

6:45 pm

Executive dinner

(By Invite Only)

February 24th

Stream 1 Chair

Dina Justice

Vice President, Regulatory Affairs

Terumo Medical Corporation

Stream 2 Co-Chair

Executive to be Announced

Medical Engineering Consultants

Stream 3 Co-Chair

Vishaka Rajaram

Sr. Director, Quality Strategy

Veeva MedTech

8:00 am - 8:45 am

registration & breakfast

8:10 am - 8:45 am breakfast workshops
Stream Two

Digital Quality: Myth vs. Maturity

Vishaka Rajaram

Sr. Director, Quality Strategy

Veeva MedTech

Session Details Arrow Icon
  • Why “going digital” hasn’t automatically improved quality performance: Understanding the gap between digitizing quality processes (QMS tools, eDHR, eQMS) and actually improving decision quality, speed, and consistency
  • Where digital quality systems break down in real operations: How fragmentation across ERP, MES, QMS, and supplier systems creates hidden disconnects in traceability, deviation handling, and CAPA effectiveness
  • Why data integrity risks are evolving, not disappearing: Moving from paper-based errors to system-level risks like poor master data governance, uncontrolled interfaces, and inconsistent validation across platforms
  • What true audit readiness looks like in a digital environment: Shifting from “audit preparation mode” to continuous inspection readiness with always-on, retrievable, and context-rich digital evidence
  • How to embed quality into day-to-day operational decision-making: Making quality signals actionable in real time, so deviations, supplier risks, and process drift influence manufacturing and supply chain decisions before issues escalate
8:50 am - 9:00 am

Chair’s Opening Remarks

Dina Justice

Vice President, Regulatory Affairs

Terumo Medical Corporation

9:00 am - 9:35 am KEYNOTE

The Next Era of MedTech Manufacturing: Transforming Operations Through AI, Robotics & Automation

Neeta Mhatre

Vice President of Global Operations COE

Intuitive Surgical

Session Details Arrow Icon
  • Moving from pilots to scale: How medtech manufacturers are moving AI, robotics and automation beyond isolated use cases and embedding them across the manufacturing operation
  • Building the intelligent factory: Connecting machines, data and people to enable real-time visibility, predictive decision-making and more responsive production environments
  • Automating quality and compliance: Leveraging AI and robotics to improve inspection, traceability, process control and consistency while maintaining regulatory requirements
  • Augmenting the workforce: Redefining operator and engineering roles through automation, while building the skills needed to work effectively alongside intelligent technologies
  • Driving measurable business impact: Where manufacturers are seeing the greatest returns—from productivity and capacity to quality, cost reduction and faster time-to-market
9:40 am - 10:15 am Case Studies
Stream One - Manufacturing & Operations

Standardizing Excellence: How to Replicate What Works Across Plants

Daniel Crain

SVP, Operations

Masimo

Session Details Arrow Icon
  • Identifying and validating best practices that can be replicated across different plants and operating environments
  • Building effective Centers of Excellence to capture knowledge, develop standards and support sites without creating unnecessary bureaucracy
  • Creating the right balance between global standardization and local flexibility across a multi-site manufacturing network
  • Establishing governance and processes that make it easier to share, adopt and sustain successful CI initiatives across plants
  • Measuring adoption and impact to ensure best practices translate into consistent improvements in cost, productivity, quality and performance
Stream Two - Supply Chain

Manufacturing at Scale and with Agility: What Large and Small Operations Can Learn from Each Other

Carlos Soto

Vice President, Global Manufacturing

Artivion, Inc.

Session Details Arrow Icon
  • Explore how people, processes, and systems evolve as manufacturing organizations scale, and how to build organizational capability without losing the knowledge and ownership that made the operation successful.
  • Examine the balance between standardization and flexibility, where common processes create value and control, and where excessive standardization can slow decisions and add unnecessary complexity.
  • Compare how organizations of different sizes innovate, make decisions, and implement change, from the speed of experimentation in smaller operations to the ability of larger organizations to scale successful solutions.
  • Discuss how leaders can take the best from both environments, the discipline, systems, and scalability of large organizations combined with the simplicity, speed, and entrepreneurial mindset of smaller ones.
  • Share practical lessons on scaling what works without scaling bureaucracy, creating operating models that remain simple, accountable, and agile as the organization grows.
Stream Three - Quality & Regulatory Compliance

Transforming Post-Market Signals into Strategy: Evaluating Complaints, Trends, and Off-Label Use to Guide Product Decisions

Dominik Reterski

Corporate Vice President Quality Assurance & Regulatory Affairs

Teleflex

Session Details Arrow Icon
  • Turning fragmented field data into decision-grade intelligence by integrating complaints, trend signals, & off-label use into a unified post-market view rather than siloed reporting streams
  • Distinguishing signal from noise in real-world data, with emphasis on identifying patterns that meaningfully indicate product performance, safety drift, or evolving clinical behavior.
  • Understanding off-label use as a system signal, using it to evaluate unmet needs, design assumptions, and potential gaps in intended use validation
  • Strengthening product lifecycle decisions through closed-loop feedback, ensuring post-market insights actively inform design updates, risk controls, & next-generation product development
  • Building organizational responsiveness to emerging risk indicators, enabling faster escalation pathways, clearer ownership, and more proactive regulatory and quality decision-making
10:15 am - 11:10 am Pre-Arranged One-To-One Meetings Arrow Icon

These mutually agreed-upon conversations are arranged and facilitated by Executive Platforms staff to ensure attendees have valuable discussions about their top-of-mind questions, challenges, and opportunities.

  • 10:20 am – 10:40am: Meeting Slot 8/Networking
  • 10:45am – 11:05am: Meeting Slot 9/Networking
11:15 am - 11:50 am Workshops
STREAM 1 WORKSHOP

The Hidden Drivers of Manufacturing Underperformance

Executive to be Announced

Hugentic, Inc.

Session Details Arrow Icon
  • Reframing underperformance from a “site execution problem” to a system design outcome shaped by how processes, flows, and governance are structured
  • Identifying how fragmented decision-making across functions and tiers creates hidden friction that accumulates into chronic performance loss
  • Moving beyond lagging KPIs to recognize early operational signals that reveal stress points in flow, capacity, and variability
  • Understanding how local optimization unintentionally drives global underperformance by improving siloed metrics at the expense of end-to-end efficiency
  • Building the capability to convert operational data into structural insight, enabling continuous redesign of how work is planned, governed, and executed
STREAM 2 WORKSHOP

From Innovation to Execution: Connecting the MedTech Lifecycle

Rene Zoelfl

Global Industry Advisor – MedTech

PTC

Session Details Arrow Icon
  • Address execution challenges across the MedTech lifecycle despite growing investments in digital tools
  • Overcome fragmented engineering, quality, and regulatory processes that contribute to delays, rework, and risk
  • Close the gap between innovation and execution through a connected, end-to-end digital thread
  • Leverage digital continuity and lifecycle intelligence to improve collaboration and accelerate development
  • Reduce bottlenecks and enable faster, more compliant, and confident decision-making across the lifecycle
STREAM 3 WORKSHOP

Empowering Supply Chain Decisions Through Actionable Metrics and Real Time Data Analytics

Executive to be Announced

Accenture LLP

Session Details Arrow Icon
  • Moving from lagging reports to real time, decision ready visibility across the end-to-end supply chain
  • Focusing on a small set of high impact metrics that directly drive operational, quality, and commercial decisions
  • Enabling end to end integration of manufacturing, quality, inventory, and logistics data for a single source of truth
  • Leveraging AI and advanced analytics to improve prediction, anomaly detection, and decision support at scale
  • Embedding insights directly into daily operational workflows to improve speed, alignment, and execution consistency
11:55 am - 12:30 pm KEYNOTE

Fireside Chat: EU MDR through the Notified Body Lens: Expectations, Variability, and MDR 2.0

Ehab Amen

Certification Division Director

GMED North America

Vivian Ngan-Winward, PhD

Principal Auditor

TÜV SÜD America

Session Details Arrow Icon
  • What Notified Bodies are actually looking for under MDR, and why technically strong products still fail or get delayed in review
  • The most common submission gaps from a reviewer perspective: clinical evidence depth, technical documentation consistency, and weak PMS integration
  • Why timelines slip in practice, misalignment between manufacturer assumptions of “complete submissions” and Notified Body readiness expectations
  • What a “reviewer-ready” submission truly means, and how manufacturers can redesign internal processes to reduce cycles, rework, and delays
  • What a future “MDR 2.0” would need to address to better balance patient safety, innovation speed, and Europe’s global competitiveness
12:30 pm - 12:35 pm

Chair’s Closing Remarks Followed by Lunch

Dina Justice

Vice President, Regulatory Affairs

Terumo Medical Corporation

12:40 pm - 1:40 pm

Networking Lunch