AAMI/FDA/BSI International Conference on Medical Device Standards and Regulation and associated meetings and symposia 

 

Health technology lifecycle: Delivering better patient outcomes

 

Preliminary program (programming and times subject to minor changes)

 

Monday, 20 April 2020 through Thursday, 23 April 2020

Monday, 20 April 2020—Preconference Symposia
10:00 am – 2:30 pm Concurrent symposia
  • Symposium 1Corporate Standards Management Symposium
  • Symposium 2MDR Deep Dive – Overview, lessons-learned; Clinical evidence requirements

2:30 pm - 3:30 pm Networking Coffee Break

Monday, 20 April 2020—Main conference and breakouts
3:00 pm – 4:00 pm
 Concurrent breakout sessions

  • Designing, Testing, and Labeling Devices for Reprocessing
  • Cybersecurity Updates from AAMI, FDA
  • IVDs and the European Regulation (IVDR)
4:15 pm – 5:15 pm Concurrent breakout sessions
  • Sterilization Packaging 
  • Medical Device Software Standards (IEC 62304, AAMI SW)
  • New IVD standards from ISO/TC 212 and FDA activities

Tuesday, 21 April 2020—Main conference and breakouts

7:00 am –  8:00 am Networking Breakfast

8:00 am – 8:15 am Welcome and introductions
8:15 am – 9:30 am Opening and Keynote: In Conversation--Ensuring the Safety and Effectiveness of Medical Devices across the Product Lifecycle

 

  • Dr. Jeff Shuren, Director of the U.S. FDA/Center for Devices and Radiological Health
  • Graeme Tunbridge, Director of Devices for the U.K. Medicines & Healthcare products

9:30 am – 10:15 am 
FDA Regulatory Update—Review and status of the U.S. FDA's new pathways for safety and performance program

10:15 am – 10:45 am Networking Coffee Break


10:45 am – 11:30 am FDA Regulatory Update—MDUFA IV—Standards update, the premarket review process and real-world evidence (NEST) 
11:30 am – 12:30 pm FDA Digital Health Program Update

12:30 pm – 1:15 pm Networking Lunch


1:15 pm – 2:15 pm Quality Management Systems—Panel discussion—What is on the horizon (e.g., FDA transition to ISO 13485, High Level Structure, Expansion of MDSAP)
2:15 pm – 3:00 pm Risk management—The Future of Risk Management

3:00 pm – 3:30 pm Networking Coffee Break

 
3:30 pm – 4:20 pm Concurrent breakouts
  • Artificial Intelligence
  • IEC 60601 Breakout—The Upcoming Revision of IEC 60601 Series
  • Regulatory Update—Latin America
  • UDI Implementation Worldwide
  • Risk Management for Combination Products (new AAMI Technical Information Report)
4:30 pm – 5:20 pm Concurrent breakouts
  • Cybersecurity
  • New ISO Labeling Standards
  • Regulatory Update—Asia/India/Gulf States 
  • QMS Breakout—MDSAP Update 
  • IEC 60601-1 Breakout—New AAMI Consensus Report: Basic introduction to complying with IEC 60601 series

5:30 – 7:30 pm—Networking Reception—Light food and spirits

Wednesday, 22 April 2020—Main conference and breakouts

7:00 am 8:00 am Networking Breakfast


8:00 am – 8:50 am
 Concurrent breakouts
  • IMDRF Update
  • Risk management—ISO 14971 and ISO TR 24971
  • Overview of developments in sterilization standards
9:00 am – 9:50 am Concurrent breakouts
  • Medical Device Software
  • Sterilization Breakout—The Industrial EO Crisis
  • TBD—Physicians Panel
  • FDA Standards Update

9:50 am – 10:15 am Coffee Break


10:15 am – 11:15 am European Regulatory Update 1: MDR: Lessons Learned
11:15 am – 12:00 pm European Regulatory Update 2: EU Clinical Requirements


12:00 pm – 12:45 pm Networking Lunch (in Hemingway Salon)

12:45 pm – 1:30 pm Clinical Investigations—Status of standards from ISO/TC 194 and ISO/TC 212, comparison of clinical investigation and performance evaluation requirements, IMDRF developments
1:30 pm – 2:15 pm  Global UDIs and Nomenclature Update

2:15 pm – 2:45 pm Coffee Break


2:45 pm – 3:30 pm Post-Market Surveillance
3:30 pm – 4:15 pm  Servicing, Refurbishing, and Repair
4:15 pm – 4:30 pm  Concluding remarks

Thursday, 23 April 2020—Post-Conference workshop
9:00 am 3:00 pm Conformity Assessment Symposium: Declarations of Conformity (DOCs) and their Role in Medical Device Submissions

Sitting at the nexus of consensus standards and medical device regulatory review, conformity assessment plays an often underappreciated role in product review. 'Declarations of Conformity' (DOCs) offer a means for manufacturers to demonstrate conformity with FDA-recognized standards without the need to include complete test reports and are a key element of FDA's proposed Accreditation Scheme for Conformity Assessment (ASCA) pilot program. 

At this workshop, we will discuss the importance of standards at CDRH, explore the utilization of DOCs, and collaborate on strategies to increase their use. 

Goal: 
Advance the use of DOCs in device submissions

Objectives

  • Demonstrate the importance of DOCs and ASCA and their significance to improving device review and potential for international harmonization
  • Brainstorm resources to promote the use of DOCs among industry
  • Foster connections between standards and regulatory affairs functions

Who should attend

  • Medical device industry: we recommend that both regulatory staff and those who work on standards development participate
  • Standards developing organizations
  • Testing laboratories (independent and in-house)

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