Overview of New Risk Management Standard: ANSI/AAMI/ISO 14971:2007
In April 2007, the latest edition of the risk management standard, ANSI/AAMI/ISO 14971:2007 — Medical devices - Application of risk management to medical devices, was completed by the international medical device community and became available to medical device manufacturers. The revised standard specifies a process for a manufacturer to identify the hazards and hazardous situations associated with medical devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control.
To assist in your understanding of the revised standard, AAMI is offering a two-hour webinar CD that:
- Provides an understanding of the changes as well as underlying philosophical approach of the 2007 edition
- Explains the organization of the 2007 edition
- Identifies the relationship of the 2007 edition to other standards
- Reviews the updated informative annexes
Don’t miss out on this opportunity to hear directly from internationally recognized representatives who were instrumental in developing ANSI/AAMI/ISO 14971:2007.
SPEAKERS
- Ed Bills, Principal Consultant, Bilanx Consulting, Committee Member of AAMI QM/WG04 on the Application of Risk Management to Medical Devices
- Stan Mastrangelo, Consultant, Committee Member of AAMI QM/WG04 on the Application of Risk Management to Medical Devices and ISO/TC 210-IEC/SC 62A JWG on Application of Risk Management to Medical Devices
WEBINAR CD
- Includes handout material and CD
- $295 for webinar registrants/ $345 for non-registrants
- Please note that 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 301-206-9789
- Mail - Select and download the order form and mail with payment to:
14971 Webinar CD Package
AAMI Publications
PO Box 0211
Annapolis Junction, MD 20701-0211
QUESTIONS?
For questions about ordering the CD, please contact AAMI's Publications at 1-877-249-8226 / 240-646-7031. For questions about CD content, please contact Virginia Schoenauer at 703-525-4890 ext. 247.