AAMI TIR45:2012, Guidance on the use of AGILE practices in the development of medical device software
This webinar provides up-to-date, detailed information about AAMI TIR45:2012, Guidance on the use of AGILE practices in the development of medical device software and its recommendations for complying with international standards and FDA guidance documents when using AGILE practices to develop medical device software.
Don’t miss this opportunity to learn more about use of AGILE practices in your medical product development effort!
| WHO SHOULD PURCHASE |
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| This webinar is intended for those who perform hands-on validation activities – R&D team members, design engineers, software developers, testers, project/program managers, process engineers, quality engineers, and regulatory personal. |
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| QUESTIONS? | |
For questions about ordering the CD, please contact AAMI publications at 1-877-249-8226 or 240-646-7031. |
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PROGRAM OBJECTIVES
- Introduction to TIR45
- Introduction to AGILE and the benefits/challenges that it poses when used in Medical Device Development
- The regulatory perspective on use of AGILE
- Key recommendations – How to get the benefit of AGILE while ensuring patient safety and compliance
- Challenges – Discussion and Q&A
SPEAKER
- John Murray, Software Compliance Expert, Office of Compliance, CDRH/FDA
- Victor Rodrigues, Head of Audiological Software Development, Cochlear Ltd
- John Schmidt, Director of Software Development, Boston Scientific Corporation
- Kelly Weyrauch, MS, Senior Principal Systems Engineer, Medtronic, Inc.
WEBINAR CD
- Time: 2 hrs
- Includes pdf of handout materials and webinar recording on CD.
- $295 for webinar registrants
- $395 for non-registrants
- domestic and international shipping rates apply
WAYS TO PURCHASE
- Online - Buy online.
- Phone - 1-877-249-8226 or 240-646-7031 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
AAMI TIR45:2012, Guidance on the use of AGILE practices in the development of medical device software
PO Box 0211
Annapolis Junction, MD 20701-0211