4th Annual EU Medical Device & Diagnostic Quality Management Workshop

DAY TWO | THURSDAY, DECEMBER 5

7:30 REGISTRATION & COFFEE

7:50 CHAIRPERSON’S OPENING REMARKS
Isabelle Kohlstetter, QRA Manager Integration, Distribution & SQA
EMEA and QRA Lead Northern Europe
CARDINAL HEALTH

8:00 WORKSHOP: DEPLOYING AN ENHANCED POST-MARKET SURVEILLANCE & VIGILANCE STRATEGY WITHIN THE QMS
Both 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 vigilance 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 LIFESCIENCES

María 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 BREAK

10:30 ENSURING CONTINUOUS QMS AUDIT PREPAREDNESS IN LIGHT OF EVOLVING CHALLENGES
While 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 WALKTHROUGH & 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 trails

Yana Pozhidaeva, Associate Director, Clinical Quality Assurance, ABBOTT

11:15 PART 2 – OPEN QUESTIONS PANEL: DIVING DEEPER INTO MDR AUDIT SPECIFICS
With 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 targeted points of discussion in order to obtain insider information of the highest value when preparing for enhanced inspections.

Yana Pozhidaeva, Associate Director, Clinical Quality Assurance, ABBOTT

Erik Vollebregt, Partner, AXON LAWYERS

11:35 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 cycle

Carsten Krafcsik, Head Regulatory Affairs Switzerland, TECAN

12:05 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 trainings

Melissa Finocchio, BIOMERIEUX

Matthias Bürger, ZIMMER BIOMET

Carsten 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 investment

Stefanie 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 costs

Melissa 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 210
Director Global Regulations & Standards, PHILIPS HEALTHCARE

4:00 CLOSING REMARKS & CONFERENCE CONCLUSION