Overview on the new AAMI/IEC 80002-1 Medical Device Software Risk Management Technical Report
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 covers:
- 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 PURCHASE
The webinar is designed for quality and regulatory compliance experts, device risk managers, software developers, and validation professionals.
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.
THREE WAYS TO ORDER
- Phone - 1-877-249-8226 / 240-646-7031 to order with credit card
- Fax - Select and download the order form and fax to 240-396-5781
- Mail - Select and download the order form and mail with payment to:
SRM Webinar CD Package
AAMI Publications
PO Box 0211
Annapolis Junction, MD 20701-0211
QUESTIONS?
For questions about ordering the CD, please contact AAMI publications at 1-877-249-8226 or 240-646-7031.