TMCnet News
Two Day Effective Complaint Handling, Medical Device Reporting and Recalls Seminar - San Diego, CA, United States - March 9th-10th, 2017 - Research and MarketsResearch and Markets has announced the addition of the "Effective Complaint Handling, Medical Device Reporting and Recalls" conference to their offering. 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. The MDR process impacts device user facilities, manufacturers, importers,and distributors. If you are a device user facility, you must report deaths and serious injuries that a device has or may have caused or contributed to, establish and maintain adverse event files, and submit summary annual reports. If you are a manufacturer or importer, you must report deaths and serious injuries that your device has or may have caused or contributed to, you must report certain device malfunctions, and you must establish and maintain adverse event files. If you are a manufacturer, you must also submit specified follow-up. Who Should Attend:
Agenda: Day 1 Schedule Lecture 1: Complaint Handling Lecture 2: Medical Device Reporting Lecture 3: Exercise and Recap of Day 1 Day 2 Schedule Lecture 1: Medical Device Reporting Lecture 2: Recalls Lecture 3: Exercise and Recap of Day 2 For more information about this conference visit http://www.researchandmarkets.com/research/lpzrb4/effective
View source version on businesswire.com: http://www.businesswire.com/news/home/20161202005509/en/ |
