Real-World Application of the FDA's Medical Device Data Systems Regulation

FDA’s regulation of Medical Device Data Systems (MDDS) applies to healthcare institutions that develop an MDDS.  Earlier this year, these institutions were required to 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. 

Building on previous AAMI webinars that provided information on understanding and preparing for FDA’s Quality System regulation, this webinar briefly reviews the regulatory requirements, provides an update from the FDA on the MDDS initiative, and offers a case study of MDDS compliance at Intermountain Healthcare. 

This webinar is essential for organizations that develop, provide, and support an MDDS. The speakers provide a road map for FDA compliance in your facility and answer any lingering questions you may have.

  WHO SHOULD PURCHASE
 
  • 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.
  QUESTIONS?
 

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

PROGRAM OBJECTIVES   

FDA Regulations Applicable to MDDS Classification

    1. 21 CFR § 820 – Quality System Regulation (QSR)
    2. 21 CFR § 807 – Establishment Registration and Device Listing
    3. 21 CFR § 803 – Medical Device Reporting (MDR)
    4. 21 CFR § 806 – Reports of Corrections and Removals
    5. 21 CFR § 801 – Labeling

Intermountain Health MDDS Case Study

    1. How we obtained Management’s attention
    2. How we inventoried applications and assessed classification
    3. Registration and listing  
    4. Management Responsibilities
    5. Document and Data Controls/Records
    6. Design Controls
    7. Corrective and Preventive Actions
    8. Supplier and Purchasing Controls

SPEAKER

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
    Real-World Application of the FDA's MDDS Regulations
    PO Box 0211
    Annapolis Junction, MD 20701-0211