Home | Search | Member Log-in | Contact | Print

Committee Detail

Committee Number: AAMI/SW
Committee Name: Medical Device Software Committee
AAMI Staff Contact: hwoehrle@aami.org
Secretariat: AAMI
Status: Active

Roster - click here

Scheduled Meetings

There are no committee meetings currently scheduled.

Working Documents - click here

Projects

Note to committee members and liaisons. Use link to 'Working Documents" above to access your documents.
Voting Committee for:
AAMI TIR32:2004, Medical device software risk management Final
AAMI TIR36:2007, Validation of software for regulated processes Final
ANSI/AAMI/IEC 62304:2006, Medical device software - Software life cycle processes Final
ANSI/AAMI/IEC TIR80002-1:2009, Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software Final
 
Author of:
AAMI TIR32:2004, Medical device software risk management Final
AAMI TIR36:2007, Validation of software for regulated processes Final
 
Develops U.S. position on:
IEC 62304:2006, Medical device software - Software life cycle processes Final
IEC/TR 80002-1:2009, Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software Final