Overview on the new AAMI/IEC 80002-1 Medical Device Software Risk Management Technical Report
March 24, 2010
11:00 am – 1:00 pm EDT
With the recent harmonization of ANSI/AAMI/IEC 62304:2006 in Europe and the continued importance of ANSI/AAMI/ISO 14971:2007 -- Medical devices - Application of risk management to medical devices, there has been a need for additional guidance on performing adequate software risk management. Using AAMI TIR32 as its starting point for development, AAMI/IEC 80002-1 was developed to provide guidance and assistance in applying ANSI/AAMI/ISO 14971:2007 to software. To assist your firm in their conformity efforts, the AAMI is pleased to offer a new webinar on the Overview on the new AAMI/IEC 80002-1 Medical Device Software Risk Management Technical Report.
PROGRAM OVERVIEW
The two-hour program will cover:
- Introduction to 80002-1
- Background and intent
- Definitions including Annex A
- Relationship to other standards and FDA requirements
- Similarities and differences with AAMI TIR32
- Elements of 80002-1
- Risk Management Process and the software lifecycle including Annex D
- Risk Management Plan and Risk Management File
- Risk Analysis and Probability
- Risk Evaluation
- Risk Control
- Risk Management Report and Annex E Safety Cases
- Production and Post Production Software Risk Management
- Annex B Direct software causes to consider versus causes with unpredictable side-effects
- Annex C Pitfalls
SPEAKERS
- Sherman Eagles, SoftwareCPR
Convener of the joint ISO and IEC working group that developed ANSI/AAMI/IEC 62304 and AAMI/IEC 80002-1
Co-chair of the AAMI software committee and member of AAMI TIR32 working group - Alan Kusinitz, Managing Partner, SoftwareCPR
Co-chair of AAMI TIR32 working group and reviewer for AAMI/IEC 80002-1
WHO SHOULD ATTEND
The webinar is designed for quality and regulatory compliance experts, device risk managers, software developers, and validation professionals.
BENEFITS FROM PARTICIPATING IN THE WEBINAR
A live webinar is one that you can “attend” and participate in right from your office. The savings are significant – no travel time or hassle and no travel expense. Invite staff members to listen and participate too - all for one low fee! It’s easy; you only need a telephone and access to the Internet.
The webinar is also interactive so you will be able to ask questions of the speakers and provide comments during the course of the program. To submit questions prior to the webinar, please e-mail them to Virginia Schoenauer at vschoenauer@aami.org.
MARK YOUR CALENDAR
| DATE | EDT |
CDT |
MDT |
PDT |
GMT |
| MAR. 24, 2010 | 11am - 1pm |
10am - 12pm |
9am - 11am |
8am - 10am |
15:00 - 17:00 |
WEBINAR MATERIALS AND DIAL-IN INFORMATION
Dial-in instructions as well as the URL address for accessing the webinar and webinar materials will be e-mailed to you one week prior to the program. If you are unable to receive your materials via e-mail, please notify AAMI’s Customer Service Center upon registration and they will mail the information and materials to you.
WEBINAR FEES
Webinar — Invite your staff and co-workers to listen in for one low price!
- $315 per registrant (AAMI Member) - unlimited registrants per site
- $415 per registrant (Non-member) - unlimited registrants per site
Please note: Your registration entitles you to one telephone connection and one computer connection at one physical location. You also have permission to make copies of the written materials for anyone else at your location who might be listening to the program with you. Any transmission, retransmission, or republishing of the audio or web portion of this program is strictly prohibited. International registrants may incur additional phone charges.
Webinar CD — Includes pdf of handout materials and webinar recording on CD. Please note that the CD will be available three weeks after the program.
- $295 for webinar registrants
- $395 for non-registrants
Please note: Domestic and international shipping rates apply.
CANCELLATION:Written requests for cancellation may be made to AAMI’s Customer Service Center until March 10, 2010. Registrants will receive a full refund, minus a $50 cancellation fee. No refunds will be provided after March 10, 2010.
FOUR WAYS TO REGISTER
- Online - Click here to register online.
- Phone - 1-800-373-3174 to order with a credit card.
- Fax - Select and download the registration form and fax to 301-206-9789.
- Mail - Select and download the registration form and mail with payment to:
Webinar Registration
PO Box 0211
Annapolis Junction, MD 20701-0211
QUESTIONS?
For registration questions, please contact AAMI’s Customer Service Center at 1-800-373-3174. For content or format questions, please contact Jeanine Hinrichs at 703-525-4890, ext. 212.