Application of Quality Management System Concepts to FDA's Medical Device Data Systems Regulation
FDA’s regulation of Medical Device Data Systems (MDDS’s) applies to healthcare institutions that develop an MDDS. Effective April 2012, these institutions must comply with FDA’s Quality System regulation. While healthcare institutions have well-established organizations, few have a Quality System that complies with FDA’s specific requirements for developers of MDDS’s.
This webinar is intended to be an introduction to the subject of a quality management system for organizations that develop, provide, and support an MDDS.
| WHO SHOULD PURCHASE |
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| Organizations that have previously developed software that has not been regulated and now need to modify their processes to accommodate the regulatory and standards requirements relevant to MDDS. Healthcare providers who need to rework their existing quality management systems to accommodate requirements and guidance for MDDS products they are developing or modifying in-house and introducing into their operations. Manufacturers of traditional medical devices who are adding MDDS products to their portfolio to tailor their existing quality management system for use with their MDDS products. |
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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
After attending this program, attendees will understand the five key quality management system processes that are discussed in the draft AAMI standard, AAMI SW87, Application of Quality Management Systems to Medical Device Data Systems (MDDS).
SPEAKERS
- Sherman Eagles, Partner, SoftwareCPR, Inc., Saint Paul, MN
- John Murray, Software Compliance Expert, Office of Compliance, CDRH/FDA
WEBINAR CD
- Includes pdf of handout materials and webinar recording on CD.
- $50 for webinar registrants
- $75 for non-registrants
- domestic and international shipping rates apply
WAYS TO PURCHASE
- Online - Click here to order 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
Application of Quality Management System Concepts to FDA's Medical Device Data Systems Regulation
PO Box 0211
Annapolis Junction, MD 20701-0211