Jelena Malinina
Director, Innovation and Digital Health
COCIR
9 June 2026
* JOIN US FOR THE PRE-EVENT HAPPY HOUR ON 8 JUNE 2026 FROM 18.00 – 19.00 CET
7.00 – 8.00 CET
Registration and Networking Breakfast
8:00 – 8:10 CET
CHAIR'S WELCOME AND OPENING REMARKS
PRODUCT DEVELOPMENT
Design & Innovation
Ravi Chana
Executive Director, Diagnostics
Association of British Healthtech Industries
QUALITY & REGULATORY
Nicolas Cors
VP, Product Development R&D
Tecan
8.10 – 8.40 CET
KEYNOTE
Peter Schulam
Chief Scientific Officer
Johnson & Johnson
Surgical Innovation: Experiences and Observations
- Integrating clinical evidence generation into MedTech R&D from concept through post-market deployment
- Applying AI and advanced analytics to reduce variability, improve decision-making, and accelerate responsible innovation
- Leveraging real-world data from connected devices to monitor performance, manage risk, and drive continuous improvement
- Designing AI-enabled products that align software, workflow, and clinician trust to deliver measurable clinical value
- Establishing governance models for AI/ML-enabled devices that balance rapid iteration with MDR and global regulatory expectations
8.40 – 9.10 CET
Plenary
Dennett Kouri
SVP, Corporate Quality, Regulatory and Clinical
Edwards Lifesciences
Inspection Readiness in Today’s Evolving Regulatory Landscape: Strategies for Resilience and Trust
- Evolving inspection paradigms, from planned visits to dynamic, risk-based regulatory oversight, and what that means for global medtech leaders
- Embedding inspection readiness into everyday operations, not just audit season, building systems that continuously demonstrate compliance
- Coordinating quality, regulatory, and clinical functions to present consistent, defensible evidence across the product lifecycle
- Leveraging data analytics and internal audit insights to anticipate inspection focus areas and prevent compliance gaps
- Case examples from Edwards Lifesciences’ global quality and audit program demonstrating readiness practices that scale across geographies and regulatory regimes
9.10 – 9.40 CET
Plenary
Carsten Hurasky
SVP and Chief Marketing Officer
QNX
Build to Last, Design to Evolve: Foundational software design as a strategic enabler
- Accelerate regulatory readiness by leveraging safety certifiable software frameworks that shorten development timelines, reduce risk, and streamline submission pathways.
- Enable continuous innovation through a modular, platform-based architecture that simplifies post market surveillance and frees engineering teams to focus on differentiated clinical and commercial value.
- Establish a secure, scalable, future proof technology foundation that ensures backward compatibility while supporting long-term product evolution and portfolio expansion.
- Position your organization for the next wave of transformation, including seamless integration of emerging technologies such as Physical AI and intelligent edge capabilities.
9.45 – 11.25 CET
Refreshments, Networking, and Pre-Arranged 1-2-1 Meetings
11.30 – 12.00 CET
Streams
Product Development
Richard Willmann, Ph.D.
VP, R&D, Image-Guided Therapy Systems
Philips
Accelerating Innovation: Strategies for Next Generation Product Development in the age of AI
- Embedding emerging technologies early to shape product roadmaps and deliver new clinical capabilities
- Co designing with clinicians to integrate workflow insights and optimize usability from the start
- Leveraging rapid prototyping and virtual simulation to shorten development cycles and reduce risk
- Designing for interoperability, scalability, and manufacturability to ensure seamless integration and reliable production
- Using real world data and feedback to drive continuous improvement and next generation innovation
Design & Innovation
Ola Hammarlund
Head, Digital Platforms
Getinge
Accelerating Digital Transformation in MedTech Through AI and Platform Innovation
- Leveraging AI-driven solutions to support clinicians with real-time insights and decision-making tools
- Designing digital platforms that improve device usability, serviceability, lifecycle efficiency, and customer value
- Embedding compliance, governance, cybersecurity, and evidence readiness into digital health innovation
- Building cross-functional collaboration across R&D, clinical, quality, regulatory, cybersecurity, IT, service, and commercial teams
- Securing executive buy-in through clear value cases, measurable KPIs, and scalable platform operating models
- Enabling patient safety and improved clinical outcomes through trusted human-technology interaction
Quality & Regulatory
Hortense Allison
VP and Head, Regulatory Medical Devices and Digital
Bayer
Melanie Donguy
Senior Director, Regulatory Medical Devices
Bayer
Inge Vandenbussche
Director, EMEA Regulatory Excellence & Intelligence | Eurasia QRA
Medtronic
Benjamin Rochette
VP, Global Regulatory Affairs
Coloplast
Fireside chat: Applying Regulatory Intelligence for Proactive Compliance Strategy
- Monitoring global regulatory changes affecting product and market access
- Developing regulatory foresight to inform portfolio and submission plans
- Using intelligence tools to track competitor approvals and trends
- Engaging early with notified bodies and regulators on evolving topics
- Prioritizing markets based on changing compliance complexity
12.05 – 12.35 CET
Workshops
Room 1
Rupam Chaudhury
Chief Segment Office - MedTech
L&T Technology Services
Case in Point: How Digital & AI Gave a Global MedTech OEM a 6–9 Month Head Start
- How AI and digital engineering compressed product development cycles by 6–9 months
- The engineering-first approach to embedding intelligence across the product lifecycle
- Real-world ROI metrics and competitive differentiation achieved through digital transformation
- A replicable framework for MedTech OEMs looking to accelerate concept-to-compliance timelines
Room 2
Günther Heling, Ph.D.
Executive Consultant
Vector Informatik GmbH
Software Defined Systems – what Med and Auto can learn from each other
- Lessons learned from history
- Characteristics of a Software Defined System
- Agile development methods suitable for safe and secure software
- Software Ecosystems speeding up development of Medical Devices to reduce go- to-market time
Room 3
Andreas Beust, Ph.D.
Chief Executive Officer
GCP-Service International
Clinical Evidence for AI-based medical devices
- Discussion of approaches to release retrained AI algorithms
- Case study for notified body pre-approval to retrain AI algorithms
- Overview of accompanying clinical evidence requirements
- Impact of AI Act implementation
12.40 – 13.40 CET
Lunch & Learn Roundtable Discussions and Open Seating Lunch
Benefit from additional learning by joining a moderated roundtable discussion on pressing issues in the industry. Registration is required, and attendance for moderated roundtables on Day 1 is limited to attendees and speakers.
Choose from:
Rupam Chaudhury
Chief Segment Office - MedTech
L&T Technology Services
AI-Powered QARA: Moving Beyond Reactive Compliance to Predictive Quality
Kim Kaplan
Manager, Principal Product, MDDAP, LLC
The Voluntary Improvement Program
Collaborative Solutions for Overcoming Industry Barriers
Carsten Hurasky
SVP and Chief Marketing Officer
QNX
Innovation, not Fixation: Leveraging Foundational Software for Lifecycle Efficiency
Adam Cargill
VP, Regulatory Strategy
Veeva MedTech
Charlène Boumard
Senior Director, Regulatory Strategy EU
Veeva MedTech
Building the AI Foundation for Medtech ROI and Scale
Gabriel Pascualy
Head, Product
Ketryx
From Bottleneck to Breakthrough: Making Compliance a Competitive Advantage in MedTech Innovation
Atul Mahajan
VP, Engineering Services
IZiel Healthcare
AI Transformation in MedTech: Lessons in Scaling and Adoption
Virginie Siloret
Global Head, Certification and Compliance
SGS
MDR & IVDR 2.0: Main changes
Bastian Krapinger-Rüther
CEO
Flinn.ai
From Noise to Signal: Using AI to Turn Complaint Intake into a Strategic Asset
13.45 – 14.15 CET
Streams
Product Development
Christoph Schmotz
VP, R&D, PSS and GSS, Healthcare Systems and Technologies
Baxter
Driving Product Development Excellence in Care & Connectivity Solutions at Baxter
- Building cross-functional collaboration between R&D, clinical, and regulatory teams to accelerate development
- Embedding user-centered design to create safer, more intuitive medical devices
- Leveraging digital twins, simulation, and rapid prototyping to shorten iteration cycles
- Scaling platforms and modular architectures to streamline portfolio management and reduce complexity
- Implementing data-driven decision-making to de-risk launches and improve patient outcomes
Design & Innovation
Carine Cochereau, Ph.D.
VP, Regulatory International
Integra LifeSciences
MDR at Maturity: From Compliance Burden to Competitive Advantage
- Transitioning from reactive MDR compliance to a proactive, value-driven regulatory strategy
- Leveraging MDR compliance as a differentiator to build international strategy
- Streamlining clinical, technical, and Labeling processes to improve efficiency and scalability
- What is still needed
Quality & Regulatory
Michael Schiffner
VP, Quality, EMEA and CWE
Siemens Healthineers
Accelerating Quality Excellence through Regulatory Innovation
- Leveraging digital quality management systems to optimize CAPA and change control processes
- Embedding regulatory intelligence to anticipate global harmonization and emerging compliance trends
- Scaling virtual audits and remote inspections via secure data-sharing platforms
- Driving continuous improvement by analyzing post-market data and regulatory feedback loops
- Cultivating a quality-first culture across operations to support rapid product introduction
14.20 – 14.50 CET
Workshops
Room 1
Kim Kaplan
Manager, Principal Product, MDDAP, LLC
The Voluntary Improvement Program
Improve Business Performance and Risk Maturity in Alignment with the FDA's QMSR
- Learn how VIP evaluates the way risks are documented, tracked, and analyzed for bi-directional traceability and proportional mitigation or contingency strategies
- See Final Guidance “Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program”
- Leveraging US FDA opportunities for expedited PMA and Site Change submissions, and more
- Boosting capacity and quality using an approach that meets your business needs
- Provide faster market access and increase sales while meeting product quality and safety standards
Room 2
Priya Bhutani
Founder and CEO
RegDesk
What High-Growth Companies Do Differently in Regulatory: From Compliance Function to Strategic Growth Engine
- How high-growth companies shift regulatory from a compliance function to a strategic driver of business growth
- Key differences between traditional regulatory models and scalable, strategy-led operating models
- Using a regulatory maturity framework to assess current capabilities and identify transformation opportunities
- The role of data-centric regulatory management in improving efficiency, visibility, and decision-making
- How modular submission design supports scalability and faster global market access
- Leveraging integrated regulatory intelligence to navigate global divergence and inform strategic planning
Room 3
Bastian Krapinger-Rüther
CEO
Flinn.ai
From Literature to Intelligence: The Evidence Gap MedTech Hasn’t Solved
- Most MedTech organisations treat clinical literature as a project input rather than a shared asset
- Evidence gets rebuilt from scratch each CER cycle, stays locked in one person’s spreadsheet, and never reaches the R&D or Quality teams who need it most.
- Structured evidence infrastructure turns literature into a queryable, reusable knowledge base that serves Regulatory Affairs, Clinical Affairs, R&D, and Quality from a single source of truth.
- To break the silo, you need to prove benefits and return on investment every step of the way: efficiency & quality gains in clinical teams are the start
14.55 - 16.15 CET
Refreshments, Networking, and Pre-Arranged 1-2-1 Meetings
16.20 – 17.05 CET
Panel Discussion
Thierry Glauser, Ph.D.
VP, Research and Development
Teleflex
Sophie Sheedy
VP, Process Engineering
Cochlear
Matthieu Menut
VP, Product Divisions, EMEA
Medline
Karsten Klose, Ph.D.
SVP, Global Digital Unit
Olympus Corporation
Thomas Haeni
VP, Research and Development, Risk Prevention
Paul Hartmann AG
Shaping the Future of Medical Device Innovation Through Innovative Product Development
- Exploring how emerging technologies are reshaping device innovation
- Maintaining agility in product development amid evolving AI regulations
- Using real-world evidence and data analytics to enhance design decisions and iteration
- Ensuring scalability across diverse care settings and patient populations
- Identifying disruptive forces likely to redefine medtech innovation over the next decade
17.05 – 17.35 CET
Plenary
Kimberly Sanchez
VP, Quality
Edward LifesciencesMichael Konings
Global Head, Regulatory Affairs, IGT Systems
Philips Medical SystemsAdam Cargill
VP, Regulatory Strategy
Veeva MedTech
The Unified Medtech Enterprise: Bridging Quality, Regulatory, Commercial and Clinical for the Next Era of Innovation
- How to quantify the impact of departmental silos on regulatory risk and commercial launch
- Strategies to optimize data flows ensuring clinical milestones trigger real-time regulatory and quality updates
- Best practices for integrating data for predictive analytics in medtech R&D
17.35 – 18.20 CET
Panel Discussion
Dennett Kouri
SVP, Corporate Quality and Regulatory
Edwards Lifesciences
Simone Diorio
VP, Quality, Infusion Therapies and Platforms
Baxter
Nickerson Hill
VP, Global Clinical Research and Regulatory Affairs
LivaNova
Susana de Azevedo Wäsch, Ph.D.
VP, Quality Management and Regulatory Affairs and Medical Affairs
YpsomedMichael Schiffner
VP, Quality, EMEA and CWE
Siemens Healthineers
Understanding how evolving MDR and global regulations are reshaping quality expectations
- Implementing modern QMS frameworks that support agility, transparency, and innovation
- Striking the right balance between accelerating innovation and maintaining rigorous safety standards
- Anticipating and mitigating quality risks through proactive, data-driven decision-making
- Leveraging cross-functional collaboration to build a culture of quality across the product lifecycle
- Defining the next phase of regulatory and quality excellence through shared lessons and emerging best practices
18.20 - 18.25 CET
Chair's closing remarks
PRODUCT DEVELOPMENT
Jelena Malinina
Director, Innovation and Digital Health
COCIR
Design & Innovation
Ravi Chana
Executive Director, Diagnostics
Association of British Healthtech Industries
QUALITY & REGULATORY
Nicolas Cors
VP, Product Development R&D
Tecan
18.25 - 19.25 CET
NETWORKING DRINKS RECEPTION
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