Considerations for Interpretation and Efficient Implementation of ANSI/AAMI/IEC 62304:2006
With the recent harmonization of ANSI/AAMI/IEC 62304:2006 in Europe, many companies will need to demonstrate conformance to their notified bodies. Understanding the philosophy and intent of the committee that developed the standard as well as recognizing the flexibility and options in the specific requirements (such as safety classification, identification of items and units, and traceability) is critical to the pragmatic and efficient implementation of the standard. To assist your firm in their conformity efforts, the AAMI is pleased to offer a new webinar CD on the Considerations for Interpretation and Efficient Implementation of ANSI/AAMI/IEC 62304:2006.EDT.
This two-hour program covers:
- Basic elements of ANSI/AAMI/IEC 62304
- Identify key elements that are subject to interpretation
- Areas critical to efficient and effective use of the standard
- Flexibility of ANSI/AAMI/IEC 62304
- Key elements to consider when tailoring it to your system
- Pitfalls to avoid
- Update on the status of related standards including:
- IEC 80002-1 Medical Device Software Risk Management
- IEC 60601-1 PEMS
SPEAKERS
- Alan Kusinitz, Managing Partner, SoftwareCPR
Co-chair of AAMI TIR32 and executive board member of AAMI SW68 - Sherman Eagles, SoftwareCPR
Chair of the 62304 working group
WHO SHOULD ATTEND
The webinar was 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.
- $295 for webinar registrants
- $395 for non-registrants
- Please note: Domestic and international shipping rates apply.
THREE WAYS TO PURCHASE
- Phone - 1-800-373-3174 to order with a 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:
AAMI - Webinar CD - ANSI/AAMI/IEC 62304
PO Box 0211
Annapolis Junction, MD 20701-0211
QUESTIONS?
For
questions about ordering the CD, please contact Publications at 1-877-249-8226 or 240-646-7031.