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Webinar On Medical Device Reporting

This webinar is intended to help you avoid FDA 483s and warning letters for failure to establish and maintain adequate procedures for medical device reporting.

This webinar is intended to help you avoid FDA 483s and warning letters for failure to establish and maintain adequate procedures for medical device reporting.Device manufacturers are required to establish and maintain medical device reporting procedures pursuant to the FDA regulations.In the United States, since December 13, 1984, the Food and Drug Administration (FDA) Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident. MDR is the mechanism for the FDA to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. To achieve compliance and to remain compliant, it is critical to understand how to define, document and implement the MDR procedure to survive FDA inspections – avoiding FDA 483s and warning letters.This webinar is aimed at helping device industry understand how to establish and maintain adequate procedures for MDR and further to provide practical and actionable perspectives by increasing awareness and familiarity of the applicable requirements.In this webinar, you will learn what is required to achieve compliance and stay compliant with MDR regulations.Areas Covered in the Session :Applicable Statues and RegulationsDefinitionsMDR Regulatory RequirementsMDR Standard Operating Procedures (SOPs): Required ElementsMDR CriteriaDetermining and Reporting MDR EventsReporting Requirements for the User Facilities, Manufacturers, and ImportersIntegrating Unique Device Identification (UDI)Enforcements:  Case StudiesCommon Mistakes and ConsequencesBest PracticesSpeaker’s PASS-IT SolutionsPrice Tags:LiveSingle Live : For One Participant$ 249Corporate Live : For Max. 10 Participants$ 899RecordingSingle REC : For One Participant - Unlimited Access for 6 Months$ 299For bookings and more information contactCompliance Trainings5939 Candlebrook Ct,  Mississauga, ON L5V 2V5,  Canada  Customer Support : 416-915-4458


14 May 2014 @ 01:00 am

14 May 2014 @ 02:00 am

Duration: 1 hours

Timezone: GMT -8:00


Online Webinar

Organised by

Compliance Trainings (deactivated)

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