Best Practices for Medical Device Reporting (MDR), Recall, Reports of Corrections and Removals

This webinar will discuss 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.
This webinar is aimed at helping device industry understand how to develop, maintain and implement the procedures for MDR, recalls, corrections and removals and further provide practical and actionable perspectives by increasing awareness and familiarity of the regulatory requirements.

At the end of the webinar, you will get empowered in a way that you would plan, develop, maintain and implement the relevant procedures efficiently and effectively.

Areas Covered in the Webinar:

• Relevant Statutes And FDA Regulations.
• Definitions.
• Regulatory Requirements For Medical Device Reporting (MDR).
• How To Report A Medical Device Problem (MDR).
• Reporting Requirements For The User Facilities, Manufacturers, And Importers.
• Regulatory Requirements for Recall, Reports of Corrections And Removals.
• Requirements To Be Addressed In the Procedures.
• Enforcements: Case Studies.

Who Will Benefit:

This webinar will be valuable for anyone in global medical device industry including, but not limited to, those working on drugs, biologics and in vitro diagnostic devices who are involved in the processes of adverse event reporting, recall, reports of corrections and removals, complaint handling and regulatory compliance.

The employees who will benefit include:

• Complaint handling personnel.
• Regulatory affairs (associates, specialists, managers, and directors).
• Clinical affairs (associates, specialists, coordinators, managers, directors and VPs).
• Quality assurance, quality control, and quality systems (associates, specialists, engineers, managers, directors and VPs).
• Research and development (associates, scientists, managers, directors and VPs).
• Product and development (associates, scientists, managers, directors and VPs).
• Marketing (associates, specialists, managers, directors and VPs).
• Site managers, and consultants.
• Contract manufacturing organization (associates, scientists, managers, directors and VPs).
• Contract research organization (associates, scientists, managers, directors and VPs).
• Senior and executive management (VPs, SVPs, Presidents and CEOs).
• Contractors and subcontractors.