Quality System Concepts Needed for FDA's Medical Device Data Systems Regulation

FDA’s regulation of Medical Device Data Systems (MDDS) applies to healthcare institutions that develops 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 provides the building blocks for understanding and preparing for FDA’s Quality System Regulation.

PROGRAM OBJECTIVES   

After attending this program, attendees will be able to:

  1. Understand what a Quality System is, and how a Quality System is helpful
  2. Discuss approaches to establishing a Quality System that supports your group and complies with U.S. regulations for Medical Device Data Systems*
  3. Describe a quality system process, and how processes relate to Quality Systems
  4. Describe the fundamentals of controlling documents in a Quality System
  5. Distinguish among documents, procedures, forms, and records
  WHO SHOULD PURCHASE
  The webinar is designed for MDDS developers in hospitals, other healthcare institutions, or small companies not currently subject to FDA regulation.  The material is relevant to hospital bioinformatics engineers, IT staff, clinical technology managers, field support personnel, telecommunications implementers, system integrators, clinical and biomedical engineers, and device risk managers responsible for MDDS.
  QUESTIONS?
 

For questions about ordering the CD, please contact AAMI publications at 1-877-249-8226 or 240-646-7031.
   

*FDA defines MDDS as a system or device “intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices: (i) the electronic transfer of medical device data; (ii) the electronic storage of medical device data; (iii) the electronic conversion of medical device data from one format to another format in accordance with a preset specification; or (iv) the electronic display of medical device data. An MDDS may include software, electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol. This identification does not include devices intended to be used in connection with active patient monitoring.”

SPEAKERS

WEBINAR CD

WAYS TO PURCHASE

  1. Online - Buy online.
  2. Phone - 1-877-249-8226 or 240-646-7031 to order with a credit card.
  3. Fax - Select and download the order form and fax to 240-396-5781.
  4. Mail - Select and download the order form and mail with payment to:

    AAMI Webinar CD
    QS Concepts Needed for FDA's MDDS
    PO Box 0211
    Annapolis Junction, MD 20701-0211