International Standards Conference - April 2019

April 24 - 25, 2019

Reston, VA

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


Download the program 
here!

Breakout sessions will address developments in standards or regulations for UDIs, mobile applications and wearable devices, Amendment 2 to IEC 60601-1, the ISO 10993 biocompatibility series, sterile packaging, robotics, and combination products.
  
Registration Fees:
$765 (AAMI Member)
$995 (Non-member)
$400 (Government Employee)
 

Hotel Information: Hyatt Regency Reston

AAMI has negotiated discounted room rates of: $229 single/double; $254 triple; $279 quad and are subject to availability. The deadline has passed, so room rates are based upon availability. Rates listed are the average/nightly rate.

To book a hotel room, 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

More Information

Questions?

Program and Registration: Kelly Hunget at khunget@aami.org or 703-253-8292

Hotel: Fred Moxley at fmoxley@aami.org or 703-253-8270