Schedule

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Tuesday 19 June 2018

SECTION 1— European Update
TIME SESSION TITLE INVITED SPEAKERS/PANELISTS DESCRIPTION
7:30–8:30 REGISTRATION/COFFEE
8:30–8:45 Opening Remarks
Gary Slack, SVP Global Medical Devices, BSI Introduction & Welcome.  BSI/AAMI working partnership, conference objectives.
8:45–9:30 Keynote Address
Howard Kerr, Chief Executive, BSI Group The future and beyond with a global NSB & NB—where next for healthcare and medical devices
9:30–9:45 Impact of MDR & IVDR on Global Business Strategy
Gary Slack
What are your expectations and understanding of the effort, resourcing, impact on business etc. on the compliance strategies necessary for regulatory compliance with the MDR & IVDR.
9:45–10:30 MHRA—a European Updated Graeme Tunbridge, MHRA, Group Manager What’s new, timelines, joint assessment, NB designation, etc.
10:30–11:00 COFFEE & NETWORKING BREAK
11:00–11:30

EU Regulations—What’s Changing

Paul Sim, KS Medical Devices Knowledge, BSI
This introductory session covers what is changing and why around the EU regulations. This high-level briefing will cover the impact of the new regulations for manufacturers and industry.
11:30–12:30
MDR—Classification, Conformity Assessment, GSPRs, Technical Documentation/PMS documentation Ibim Tariah, Technical Director, America's Medical Devices, BSI
Get an overview of the MDR Annexes including Classification Rules (Annex VIII), Conformity Assessment (Annex IX-XI), General Safety and Performance (Annex I), Technical File Documentation (Annex II) and Post-Market Surveillance Technical Documentation (Annex III).
12:30–13:30 LUNCH & NETWORKING BREAK
13:30–14:30 IVDs— In Vitro Diagnostics Stefan Burde, Technical Specialist & Scheme Manager IVDs, BSI Review the requirements for IVDs arising from the MDRs and the IVDRs.
14:30–15:30 MDR—Risk and Clinical Requirements Ibim Tariah
Dig deep into the Risk and Clinical Requirements under the MDR. Topics include, risk-benefit analysis, clinical investigations, when a clinical investigation is required, expectations above and beyond MDEDEV 2.7.1 Rev 4, and changes to conformity assessment procedures.
15:30–15:45 COFFEE & NETWORKING BREAK
15:45–16:30 pm Risk Management—Revision of ISO 14971 and critical issues for the future Jos van Vroonhoven, Philips
Anette Sjogren, Preventia, Sweden
Patty Krantz-Zuppen, Medtronic
Review of the changes being considered in the balloted revision of ISO 14971 and, with the panel, discussions on the future direction of risk management for medical technology.
16:30–17:15 Postmarket Surveillance—Update on European, FDA and initiatives in Postmarket Surveillance and development of the ISO work on postmarket surveillance Arjan van Drongelen, RIVM Convener ISO TC 210 WG6
Tony Sant, MHRA
Cait Gatt, Boston Scientific
The panel will discuss the FDA and ISO efforts to address postmarket surveillance and vigilance.
17:15–17:30 Chairman’s Closing Remark Gary Slack
Any final questions, summary of Day 1, and introduction to Day 2.
17:30–19:00 NETWORKING RECEPTION


Wednesday 20 June 2018

SECTION 2—International Update
TIME SESSION TITLE SPEAKERS/PANELISTS DESCRIPTION
8:30−8:45
Chairman’s Opening Remarks Dr. Eamonn Hoxey, AAMI Chair, E.V. Hoxey LTD Any questions from Day 1, introduction to Day 2
8:45–9:15 IMDRF Update—Update on IMDRF initiative and related regulatory actions—Standards, Good Regulatory Practice, UDIs, Essential Principles

Jeff Eggleston, Global Standards, Medtronic
Gail Rodriguez, FDA/CDRH
Melissa Torres. FDA/CDRH

A panel of industry and regulatory experts review the work of the IMDRF and related regulatory actions related to standards, Good Regulatory Practice, UDIs, and Essential Principles.
9:15–9:45 MHRA—Global regulation and harmonization John Wilkinson, Director Devices MHRA MHRA perspective and involvement in internatonal regulatory initiatives
9:45–10:15 FDA—Global regulation, harmonization and transformation

Gail Rodriguez, FDA/CDRH
Melissa Torres, FDA/CDRH

Update of FDA initiatives, areas of focus, recent program changes and organizational changes
10:15–10:35 AAMI—Global standards for medical technology Rob Jensen, President and CEO, AAMI AAMI perspective on current and future standards' efforts to enable better patient outcomes by improving the safety, efficacy, and availability of medical technology
10:35–11:00 COFFEE & NETWORKING BREAK
11:00–12:00 Where next for IEC 60601? Michael Appel, MD, Chair, IEC/TC 62 – Electrical equipment in medical practice, Chief Patient Safety Officer, Northeast Georgia Health Systems, Inc.

Jeffrey Eggleston, PE – Secretary, IEC/SC 62D – Electromedical equipment, Global Standards Advisor, Medtronic

Richard Scott, BSc, MSc, PhD, CEng, MIET, CSci, FIPEM, Chair, IEC/SC 62A – Common aspects of electrical equipment used in medical practice, Head of Clinical Engineering, Sheffield Teaching Hospitals NHS Foundation Trust
Interactive session with audience to review and discuss medium and long-term plans for upcoming revision of the IEC 60601 body of standards for electromedical devices (4th editions).
12:00–12:30 Artificial Intelligence and Medical Algorithms Pat Baird, Philips Healthcare Review ongoing efforts to explore educational, regulatory and standards needs relating to artificial intelligence and algorithms utilized in clinical care technology.
12:30–13:30 LUNCH & NETWORKING BREAK
13:30–14:15 Medical Device Quality Systems—Today and Tomorrow

Session 1—The Present: What is happening today with respect to quality systems
Eamonn Hoxey, E.V. Hoxey, LTD
Paul Sim, BSI
Anette Sjogren, Preventia, Sweden
Melissa Torres, FDA/CDRH

Session 1 focuses on current activities and short-term expectations with respect to QS, including:

  • Implementation of ISO 13485:2016 (deadlines for implementation)
  • Update on MDSAP (Single Accreditation Program)
  • Update on Case for Quality
  • ISO Quality Management Handbook
  • EU recognition and mapping to the MDD & MDR (including planned CEN Technical Report)
14:15–15:00
Medical Device Quality Systems—Today and Tomorrow

Session 2—The Future: What additional changes to QMS regulations, standards and implementation may be coming in 2019 and beyond

Session 2 focuses on longer-term changes:

  • Update from FDA on QSM regulations
  • Plans for future alignment of ISO 13485 with ISO 9001:2016 and ISO High Level Management Structure
  • QMS for ancillary sector
15:00–15:15
Closing Remarks Dr. Eamonn Hoxey, AAMI Chair  
15:15 COFFEE, NETWORKING, AND DEPARTURE

 

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