This 90-minute webinar will discuss the requirements and compliance under the applicable FDA regulations for medical device reporting (MDR), recall and reports of corrections and removals in the US. It is designed to help the audience develop, maintain and implement adequate procedures.
Why Should You Attend:
The FDA's 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. Device firms are also subject to compliance to the FDA regulations of device recalls, reports of corrections and removals. To achieve compliance and to remain compliant, it is critical to understand how to define, document and implement the procedures for MDR, recalls, corrections and removals.