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Event Registration - AAMI/BSI/FDA International Standards Conference - April 2019

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Start Date:
Wednesday, April 24, 2019
End Date:
Thursday, April 25, 2019
8:00 AM - 5:00 PM Eastern Daylight Time

The AAMI/BSI/FDA International Conference on Medical Device Standards and Regulation will be held on 24-25 April 2019 at the Hyatt Regency Reston, 1800 Presidents St, Reston, VA 20190.  The conference will provide updates and analysis of new FDA initiatives and European Medical Device regulation and will review changes to key international standards.

The programme includes two keynote presentations; one comparing safety perspectives in healthcare with the airline industry and the other providing a insight on future trends in regulations of medical devices from the UK MHRA. Other sessions include:

  • FDA updates on
    • The new safety and performance pathway
    • The Accreditation Scheme for Conformity Assessment (ASCA) of medical devices
    • The programme for the adoption of standards
    • The digital health initiatives
  • Machine learning and artificial intelligence in medical technology
  • Implementation of the European Medical Devices Regulations with a focus on:
    • Clinical evidence
    • Technical documentation
  • Implications of Brexit
  • Updates and practical experiences of 
    • The International Medical Device Regulatory Forum (IMDRF)
    • The Medical Devices Single Audit Programme (MDSAP)
  • Updates on standards and regulations for
    • Quality management systems for medical devices
    • Cybersecurity
    • Risk management
    • Medical device software
    • Post-market servicing, repair and refurbishment
    • Interoperability
    • Sterilization and packaging for sterile devices
    • Unique Device Identification (UDI)
    • Medical electrical equipment
    • Good clinical practice
    • Device labelling and instructions for use

$765 (AAMI Member)
$995 (Non-member)
$400 (Government Employee)

Book your hotel room today at the Hyatt Regency Reston: click here!

Alternative Hotels Nearby:
The Westin Reston Heights - 1.6 miles
Sheraton Reston - 1.4 miles
Hyatt House - 1.7 miles
SpringHill Suites Herndon Reston - 1.4 miles
Hampton-Inn & Suites Herndon-Reston - 1.5 miles
Residence Inn Herndon Reston - 1.7 miles

  • Event Location
    • Address:
      Hyatt Regency Reston
      1800 Presidents St
      Reston, VA 20190
  • Event Notes
    • Cancellations and Substitutions. . . All cancellation and substitution requests must be made in writing to AAMI Customer Service.
      Cancellations. . . Written requests for cancellation may be made to AAMI Customer Service until April 5, 2019. Registrants will receive a full refund, minus a $75 administrative fee. No refunds will be provided after April 5, 2019.
      Substitution . . . If the registrant is unable to attend, substitutions are welcome and can be made at any time, including at on-site registration. Please email any registration changes to AAMI Customer Service or fax them to 703-525-1424.
Registration is closed. Please contact Kelly Hunget khunget@aami.org.