DISTINGUISHED PRESENTERS INCLUDE:

NOTIFIED BODY SPEAKERS:

MEDICAL DEVICE & DIAGNOSTIC INDUSTRY SPEAKERS:

Ensuring QMS Preparedness in Light of the MDR & IVDR with a Focus on Economic Operator

Compliance, Enhanced Supplier Control & Optimal Design of a Robust PMS Strategy, Successfully

Managing International Audit Readiness, all while Digitalizing QMS Processes & Data

#Q1EUQUALITY#Q1PRODUCTIONS

Michael BotheCo-Head of Certification Body Active Medical Devices DQS MEDIZINPRODUKTE

Melissa FinocchioSr. Director, Global Quality - Business & Support BIOMERIEUX

Angeles SanfranciscoManager International Quality Compliance EDWARDS LIFESCIENCES

Isabelle KohlstetterQRA Manager Integration, Distribution & SQA EMEA and QRA Lead Northern Europe CARDINAL HEALTH

Noel ButterworthEU PDO, Quality & Operations Manager MEDTRONIC

Erik VollebregtPartner AXON LAWYERS

Martin GeertsemaEMEA Director, Quality Assurance & Regulatory AffairsCONMED

Sabine OhseHead of Notified Body IVDMDC - MEDICAL DEVICE CERTIFICATION

Peter LindersDirector Global Regulations & Standards PHILIPS HEALTHCARE

Mayda López-BelmonteDirector Quality & Regulatory Compliance Spain, and Innovation EMEA JOHNSON & JOHNSON

Keri TaylorRegulatory Compliance Manager & Project Manager ABBOTT, STRUCTURAL HEART

Benjamin KaufholdQuality Management & Regulatory Affairs BOSCH HEALTHCARE SOLUTIONS

Yana PozhidaevaAssociate Director, Clinical Quality Assurance ABBOTT

Carsten KrafcsikHead Regulatory Affairs SwitzerlandTECAN

Marta CarnielliIVD Technical OfficerTÜV SÜD

Matthias BürgerVP Global Regulatory & Quality Assurance ZIMMER BIOMET

Stefanie LeschonskyVP Quality & Regulatory Affairs DRÄGERWERK

David LansbergenManager Regulatory Affairs & Quality, EMEA SAKURA FINETEK EUROPE

Geneviève MichauxPartner KING & SPALDING LLP

Laure Le CalvéManaging Partner LCH

Wolfgang WernerSenior VP Regulatory & QualityBIOVOTION

María José LópezManager Quality Compliance CCVEDWARDS LIFESCIENCES

DECEMBER 4-5, 2019 | FRANKFURT, GERMANYLE MERIDIEN FRANKFURT HOTEL

4TH ANNUAL

EU MEDICAL DEVICE & DIAGNOSTIC QUALITY MANAGEMENT CONFERENCE

#Q1EUQUALITY#Q1PRODUCTIONS

4TH ANNUAL

EU MEDICAL DEVICE & DIAGNOSTIC QUALITY MANAGEMENT CONFERENCEDECEMBER 4-5, 2019 | FRANKFURT, GERMANY

DAY ONE - WEDNESDAY DECEMBER 48:00 REGISTRATION & WELCOME COFFEE 8:45 CHAIRPERSON’S OPENING REMARKS9:00 OPENING ICE BREAKER: SHARING LESSONS LEARNED IN ALIGNMENT OF QMS WITH MDR & IVDRThe interactive ice breaker will open the event with an opportunity for participants to move around the room with the goal of meeting other delegates and engaging in swift discussions. The audience is encouraged to briefly exchange 2 important lessons learned thus far within steps taken to transition QMS compliance to MDR or IVDR requirements. Participants in this warm-up session are also given the opportunity to build contacts with industry peers, kicking off the event networking platform.

9:20 ROUNDTABLE: UNVEILING NOTIFIED BODY PERSPECTIVES IN UPDATED & NEW QUALITY REQUIREMENTSAs the device and diagnostic industries continue to prepare quality management systems for compliance with the new regulations, lingering questions and areas of uncertainty persist. From technical file content to proactive post-market surveillance and QMS data management, clar-ification is needed from notified bodies to ensure relevant measures are applied in due time. This interview session led by an industry represen-tative will enable the audience to address specific questions to notified bodies, with the aim of shedding light into timely and helpful information, all while clarifying areas of divergence among regulators.MODERATOR: Marta Carnielli, IVD Technical Officer, TÜV SÜD PANELISTS: Sabine Ohse, Head of Notified Body IVD MDC - MEDICAL DEVICE CERTIFICATIONMichael Bothe, Co-Head of Certification Body Active Medical Devices, DQS MEDIZINPRODUKTE

10:20 COFFEE & NETWORKING BREAK10:45 INDUSTRY-SPECIFIC SMALL GROUP DISCUSSIONS: ACHIEVING A UDI SYSTEM ENCOMPASSING EU REQUIREMENTSWhile medical technology manufacturers are familiar with UDI rules for the US market among others, requirements within the MDR and IVDR differ and introduce new areas of focus. Medical device and higher class IVD quality professionals are in the process of revising existing strategies to incorporate MDR provisions without developing a distinct process in order to contain costs and ultimately streamline operations, while lower risk IVD professionals with up-classified prod-ucts are in the midst of developing a traceability strategy for the first time. Participants in this session are given the opportunity to gather and exchange with peers from the same industry to share challenges and solutions in the implementation of EU UDI compliance through focused small group discussions led by knowledgeable facilitators.Benjamin Kaufhold, Quality Management & Regulatory Affairs BOSCH HEALTHCARE

11:30 MASTERCLASS: ENHANCING ECONOMIC OPERATOR MANAGEMENT & STRENGTHENING SUPPLIER CONTROL The MDR and IVDR introduce new definitions and roles for all stake-holders involved in the medical technology supply chain, with the goal of ensuring increased safety for the end-user. The scope extends to additional responsibilities focused on vigilance and regulatory compli-ance verification, incumbent to importer and distributor partners and impacting existing contracts. In addition, much focus is set on enhancing supplier control and supervision in order to have full visibility on 3rd party quality systems and manufacturing processes.

PART 1 – OVERVIEW OF ECONOMIC OPERATOR REQUIREMENTS• MDR/IVDR definition of economic operators• Mapping a comprehensive supply chain• Revising partnerships & contracts• Quality checks & compliance verificationMayda López-Belmonte, Director Quality & Regulatory Compliance Spain, and Innovation EMEA JOHNSON & JOHNSON

12:00 LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES1:15 PART 2 – PANEL DISCUSSION: REVISED SUPPLY CHAIN STRATEGY COMPLETION • Implementing supply chain verification with partners• Vigilance & complaint handling processing concerns• Limits in the training & management of partners• Small vs. large company: Differences in strategiesMatthias Bürger, ZIMMER BIOMETMayda López-Belmonte, JOHNSON & JOHNSONIsabelle Kohlstetter, CARDINAL HEALTH

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2:00 PART 3 – SMALL GROUP DISCUSSION: SOLIDIFYING SUPPLIER EVALUATION & CONTROLTo fulfill stringent MDR and IVDR requirements and obtain full visibility into a supplier’s quality system, direct auditing of suppliers’ manufac-turing sites is considered most efficient. However, the time and cost involved prove challenging for many organizations, particularly mid-sized and small. This small group discussion divided by industry and company size, focuses on peer-to-peer sharing to give the audience a unique opportunity to exchange strategies for better control of suppliers, and debate best practices within each industry.Melissa Finocchio, Sr. Director, Global Quality - Business & Support BIOMERIEUX Martin Geertsema, EMEA Director, Quality Assurance & Regulatory Affairs CONMED3:00 PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE: ROLE & INVOLVEMENT IN QUALITY MANAGEMENT• PRRC’s exact role within the organization & quality team• Incumbent responsibilities & extent of liability considerations• Lessons learned from the Qualified Person role in pharma • Portraying & identifying the ideal candidate for the positionErik Vollebregt, Partner AXON LAWYERS

3:30 COFFEE & NETWORKING BREAK 4:00 BRIDGING CLINICAL & QUALITY TO MASTER CLINICAL ASPECTS OF THE QMSWith a strongly enhanced focus on risk mitigation and management for the end-user, the MDR and IVDR demand for accentuated attention to be set on clinical testing both in the pre and post-market phases. The clinical evaluation plan, including post-market clinical follow-up, as an integral component of quality management as well as post-market surveillance and vigilance measures, must now be fully understood by quality professionals in order to demonstrate compliance in the case of an audit without relying on clinical teams. It is therefore critical to enable further clinical knowledge into quality professionals via proper training and transparent communication between both teams, and ultimately move away from siloed organizational structures.• Partnering with clinical to enhance risk management• Clinical training curriculum for quality professionals• Efficiently balancing clinical knowledge transmission• Enabling quality teams to explain the PMCF planYana Pozhidaeva, Associate Director, Clinical Quality Assurance ABBOTT

4:30 INDUSTRY-SPECIFIC SMALL GROUP DISCUSSIONS: SHARING SOLUTIONS TO TIMELY MDR/IVDR COMPLIANCE CHALLENGESWhile the medical device and diagnostic industries face different time-frames for compliance with respective regulations, necessary action must swiftly be taken to bring the regulatory transition to completion by the deadlines. Quality professionals continue to address pressing challenges and aim to organize final steps in a practicable manner in order to ensure new and updated provisions are implemented. This peer-to-peer discussion format, led by knowledgeable moderators enables participants to gather in small groups divided by industry, to identify and dive deeper into specific areas of concern for each delegate, and brainstorm solutions to problems raised all while sharing strategies from individuals’ experience. Group 1 – Medical Devices: Wolfgang Werner, BIOVOTIONGenevieve Michaux, KING & SPALDING LLPGroup 2 – IVDs: David Lansbergen, SAKURA FINETEK EUROPE Laure Le Calvé, LCH

5:30 CLOSING REMARKS & DAY 1 CONCLUSION6:15 CONTINUED NETWORKING: FACILITATED GROUP DINNERS With the immense value in peer-to-peer interaction and experience sharing, we wish to provide attendees with an opportunity to continue networking after the first day of the conference. Q1 Productions will arrange dinner reservations at local restaurants close to the conference hotel for those interested in joining a group of fellow participants for dinner on December 4th. Please note that dinner expenses must be covered by each participant individually.

#Q1EUQUALITY#Q1PRODUCTIONS

DAY TWO - THURSDAY DECEMBER 5

At Q1 Productions, our craft is the research, development and execution of engaging educational programs which surprise and delight participants through high level, strategy driven content which blends didactic learning alongside hands-on, kinesthetic learning formats to truly deliver a robust educational experience. What sets our programs apart is the dedication to high quality content, the research behind the development of just-in-time topics which are forward thinking and relevant, as well as the strong partnerships we foster with speaker faculty across the industry. Programs are constantly evolving to remain relevant for participants, and to ensure that content and delivery provide a unique educational experience, for attendees, sponsor partners and presenters. We strive to deliver on our promise of quality first, from start to finish.

ABOUT THE ORGANIZERS

4TH ANNUAL

EU MEDICAL DEVICE & DIAGNOSTIC QUALITY MANAGEMENT CONFERENCEDECEMBER 4-5, 2019 | FRANKFURT, GERMANY

7:30 REGISTRATION & COFFEE7:50 CHAIRPERSON’S OPENING REMARKS8:00 WORKSHOP: DEPLOYING AN ENHANCED POST-MARKET SURVEILLANCE & VIGILANCE STRATEGY WITHIN THE QMSBoth the MDR and IVDR include an enhanced focus on mitigating risks in medical technology use once on the market, as well as the establishment of proactive measures to ensure proper monitoring of product performance and safety. With the larger amount of relevant data to collect and process than under the directives, coupled with challenges when juggling multiple product lines, quality professionals are focused on organizing a comprehensive chain of requirements all while containing costs. This interactive workshop will enable the audience to dive into the practical aspects of refining the post-market surveillance blueprint in light of, and in time for new rules, all while sharing insight into initial lessons learned in the transition process.Angeles Sanfrancisco, Manager International Quality Compliance EDWARDS LIFESCIENCESMaría José López, Manager Quality Compliance CCV EDWARDS LIFESCIENCES David Lansbergen, Manager Regulatory Affairs & Quality, EMEA SAKURA FINETEK EUROPE

9:15 FOCUS ON RISK MANAGEMENT IN QMS CHANGE CONTROL • QMS change control plan alignment with risk management• Ensuring thorough documentation of the process• Knowledge management as basis for risk management• Post-market change control & effectiveness Noel Butterworth, EU PDO, Quality & Operations Manager MEDTRONIC

10:00 COFFEE & NETWORKING BREAK10:30 ENSURING CONTINUOUS QMS AUDIT PREPAREDNESS IN LIGHT OF EVOLVING CHALLENGESWhile quality management and assurance professionals strive for full compliance with target market requirements at all times, satisfying differing sets of provisions proves tedious, particularly for global corporations. With the first MDR audits taking place ahead of the transition deadline, quality teams are eager to obtain practicable information from peers having experienced the challenge.

PART 1 – FIRST MDR AUDITS: PRACTICAL WALK-THROUGH & NEW AREAS OF CHALLENGE • Auditor focus on QMS alignment with MDR• QM staff ability to explain other teams’ compliance• Misconceptions on QMS changes ahead of MDR• Change management & enhanced QMS data trailsKeri Taylor, Regulatory Compliance Manager & Project Manager ABBOTT, STRUCTURAL HEART

11:15 PART 2 – OPEN QUESTIONS PANEL: DIVING DEEPER INTO MDR AUDIT SPECIFICSWith much curiosity and concern surrounding MDR audits and new areas of challenge for quality teams, the audience is invited to actively engage in a live questions and answers session with the panelists. This format enables participants to freely address specific and tar-geted points of discussion in order to obtain insider information of the highest value when preparing for enhanced inspections.Keri Taylor, Regulatory Compliance Manager & Project Manager ABBOTT, STRUCTURAL HEARTErik Vollebregt, Partner AXON LAWYERS

11:45 PART 3 – OVERCOMING MDSAP READINESS CHALLENGES• QMS structure to incorporate international requirements• Streamlining the compilation of large volumes of data• Maintaining readiness through the 3-year audit cycleCarsten Krafcsik, Head Regulatory Affairs Switzerland TECAN

12:15 LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES

1:15 PART 4 – PANEL DISCUSSION: SIMULTANEOUSLY MANAGING QMS OPERATIONS & FREQUENT AUDITS• Increasing frequency of different types of audits• Handling auditor requests all while achieving daily goals• Quality team structure enabling sufficient staffing at all times • Establishing mock audit programs & continuous trainingsMelissa Finocchio, BIOMERIEUXMatthias Bürger, ZIMMER BIOMETCarsten Krafcsik, TECAN

1:45 TECH TALK: OPPORTUNITIES IN DIGITIZING QUALITY SYSTEM DATA • Advantages of data automation in quality operations• Decreasing inconsistencies by centralizing QS data• Tools & technology for end-to-end data management • Master Data Management implementation challenges• Initial expenditure vs. forecasted return on investmentStefanie Leschonsky, VP Quality & Regulatory Affairs DRÄGERWERK

2:30 COFFEE & NETWORKING BREAK 2:45 OPTIMIZING EFFICIENCY & COMPLIANCE BY ESTABLISHING A GLOBAL QUALITY MANAGEMENT STRATEGY When quality teams are dispersed in different markets internationally, corporate goals and processes are commonly not pursued in the same manner, enhancing the risk of non-compliance with local and international rules. To ensure a streamlined and harmonized approach to quality management, device and diagnostic organizations working in disparate markets aim to develop international strategies allowing for better exchange of information from various geographies and strengthening the overall process. Moving from a country-specific to a sustainable worldwide quality strategy promises optimized and streamlined operations, if and when a comprehensive blueprint is designed to successfully deploy the harmonization plan.• Design of the harmonization strategy with a focus on: » A sustainable process » Enhanced compliance » Improved data exchange• Considering technology to achieve standardization • Realistic approach to implementation timelines• Forecasted impact on quality management costsMelissa Finocchio, Sr. Director, Global Quality - Business & Support BIOMERIEUX

3:30 OUTLOOK INTO THE FUTURE OF ISO 13485• Outcomes of recent ISO/TC 210 meeting• Potential for a new revision to ISO 13485• Impact on medical technology QMS Peter Linders, Chair ISO/TC 210Director Global Regulations & Standards PHILIPS HEALTHCARE

4:00 CLOSING REMARKS & CONFERENCE CONCLUSION

#Q1EUQUALITY#Q1PRODUCTIONS

Melissa Finocchio, Sr. Director, Global Quality - Business & Support BIOMERIEUX

Melissa Finocchio is the Senior Director for Global Quality Business & Support Functions at bioMérieux, a world leader in in vitro diag-nostics based in Lyon, France. She received her undergraduate degree in Engineering Man-agement from the University of Missouri-Rolla

and a Master’s of Arts in Quality Management from Webster University. With more than 19 years’ experience in the medical device industry, Melissa has held various positions in product development, project management, complaint handling, label-ling, and quality. Having lived and worked in multiple countries, she has experienced first-hand the challenges of cross-cultural communication, international management, and change man-agement on a global scale.

Matthias Bürger, VP Global RA/QA EMEAZIMMER BIOMET

Mr. Buerger is the Vice President Regulatory Af-fairs and Quality Assurance EMEA for Zimmer Biomet. He has a Master’s of Science degree in Biomedical Engineering from Marquette Uni-versity in Milwaukee, WI, as well as a Dipl. Ing. degree in Electrical Engineering from Fach-hochschule Dieburg in Germany. In the past

Mr. Buerger has had a variety of different management roles in QA and Regulatory Affairs for companies including GE, Baxter, Terumo & Guidant. He has also worked as a Quality Manage-ment Systems and Operational consultant for Grant-Thornton, as well as spending time as a lead auditor and test engineer for TUV Rheinland, a European Notified Body. Mr. Buerger has spoken at a variety of international conferences, including RAPS, MD&D, ASQ, IEEE and others.

KEY SPEAKER HIGHLIGHT:

WHO SHOULD ATTEND:

SPONSORSHIP OPPORTUNITIES:

PREVIOUS Q1 ATTENDEES INCLUDE:

Organizations currently manufacturing medical technologies from a wide range of therapeutic areas will find this conference of tremendous interest, given the wide-ranging reach of new regulatory requirements across Europe. With dozens of years of combined regulatory experience specific to the device industry, presenters will address valuable presentations highlighting both the challenges faced by manufacturers, as well as strategies for overcoming the increasingly strict regulatory environment. Ex-ecutives with the following functions will find this program of specific interest:• Quality Assurance• Quality Management System• Regulatory Affairs• Supplier Control• Qualified Person • Person Responsible for Regulatory Compliance

At this time, there are a variety of sponsorship and exhibition opportunities available for companies wishing to increase their visibility and participation in the program, ranging from keynote speaking opportunities through to exhibitor and documentation sponsors. Organizations most suitable for this type of exposure provide services and solutions including:• Quality Assurance & QMS Consultants & Trainers• International Regulatory Consultants• Validation Software Providers• UDI Technology Specialists• Quality Assurance Software Providers• MDM & Data Management Software Developers

Director, Supply Chain QA, ABBOTTDVP Global Quality Assurance, ABBOTT DIAGNOSTICSRegulatory Affairs Manager, AXIS-SHIELDPost-Market QA & RA Manager, BECKMAN COULTERVP of Quality & Regulatory, BECTON DICKINSONDirector, Product Labeling & Documentation, BIOMERIEUXQuality Manager, BIOM’UPGlobal Director Regulatory Affairs, BIOSENSORSVP Quality & Regulatory Management, BONESUPPORTManager of Quality Assurance, BOULE MEDICALHead of Clinical & Regulatory Affairs, BSI GROUPIVD Expert & Auditor, BSI GROUPHead of Quality Assurance, COLOPLASTManager of Quality Assurance, COPAN ITALIACompliance & Quality Manager, DEPUY FRANCEVP Quality & Regulatory Affairs, DEVICOR MEDICAL PRODUCTSQuality Assurance Manager, DIASORINEU Regulatory Compliance Mger, EDWARDS LIFESCIENCESVP International Regulatory Affairs, EDWARDS LIFESCIENCESAssociate EU Director of Quality Assurance, EXONHIT

QA Manager Surveillance, GAMBRO DIALYSATORENDirector QA/RA, GAMBRO DIALYSATORENRegulatory Affairs Leader EMEA, GE HEALTHCAREPublic Policy Manager, GS1 GLOBAL OFFICEDirector of Quality & Regulatory Management, HEMOCUEDirector, Regulatory Affairs, HEMOTEQEMEA Quality Director, ILLUMINADirector EU Quality, IMMUCORQuality & Regulatory Director, INION

Head of QA & RA, JENAVALVE TECHNOLOGYInternational Manager of Quality Assurance, KARL STORZSenior Director RA/QA, LIFESCANVP RA & QA, LEICA MICROSYSTEMSQuality Assurance Engineering Supervisor, MEDTRONICSenior Global Quality Assurance Manager, MEDTRONICQuality & Regulatory Manager, NOX MEDICALQuality Manager, ORBUSNEICH MEDICALDirector, Quality & Regulatory Affairs, PHILIPS-MEDISIZEDirector Quality Assurance & RA, POLYGANICSHead, EU Quality Assurance, QIAGENDirector Quality Assurance, RANIER TECHNOLOGYSr QA & RA Engineer, RAYSEARCH LABORATORIESHead of Quality Management & RA, ROCHE DIAGNOSTICSDirector Quality Systems, SIEMENSDirector Quality Management, SIEMENSDirector of Quality Assurance, SYMETISQuality Assurance & Regulatory Affairs Director, SYSTELAB

Director RA/QA, TELEFLEX MEDICALQA/RA Director, THE MAGSTIM COMPANYDesign Quality & Compliance Manager, THERMO FISHERQuality/ Regulatory Affairs Manager, VENNER MEDICALDirector, International QA & RA, WELCH ALLYNVP Quality Mgmt & Environmental Affairs, WELLSPECT

Group QA/RA Director, WERFEN LIFE GROUPQuality Assurance Manager EMEA, WRIGHT MEDICAL

Head of Quality Assurance, YPSOMEDManager Quality Systems Engineering, ZIMMER BIOMETDirector Quality Systems, ZIMMER BIOMET

4TH ANNUAL

EU MEDICAL DEVICE & DIAGNOSTIC QUALITY MANAGEMENT CONFERENCEDECEMBER 4-5, 2019 | FRANKFURT, GERMANY