2-day In-person Seminar on “Effective Complaint Handling, Medical Device Reporting and Recalls” at Boston

Effective Complaint Handling, Medical Device Reporting and Recalls

25 26 July 2013

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An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.

Medical Device Reporting (MDR) is the mechanism for FDA to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. User Facilities (e.g., hospitals, nursing homes) are required to report suspected medical device related deaths to both the FDA and the manufacturers. User facilities report medical device related serious injuries only to the manufacturer. If the medical device manufacturer is unknown, the serious injury is reported by the facility to FDA. Health professionals within a user-facility should familiarize themselves with their institution procedures for reporting adverse events to the FDA.

Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

1 speaker

2 sessions

Day 1 from 9am to 6pm Thursday 25th July 2013

Day 2 from 9am to 6pm Friday 26th July 2013

Hilton Boston Logan Airport

United States United States / Boston

One Hotel Drive, Boston, Massachusetts, United States, 02128

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2 known attendees

  • GlobalCompliancePanel
  • David R. Dills

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