Implementing a Medical Device Reporting (MDR) System Integrated with a UDI System

Website https://www.compliance2go.com/product/?pid=CP2014-289 | Edit Freely

Category Biotechnology , Healthcare , Medical Device , Pharmaceutical

Deadline: May 07, 2014 | Date: May 07, 2014

Venue/Country: houston, U.S.A

Updated: 2014-02-14 15:46:36 (GMT+9)

Call For Papers - CFP

This webinar is intended to help you get familiar with the Medical Device Reporting (MDR) pursuant to the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act).

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 with FDA’s updated MDR requirements, it is critical to understand how to define, document and implement the adequate and sustainable MDR procedures by integrating new requirements.

This webinar is aimed at helping device industry understand how to establish MDR procedures and further provide practical and actionable perspectives by increasing awareness and familiarity of the applicable regulatory requirements including integrating a UDI system.

This webinar will help you establish and maintain an MDR system in a less burdensome, systematic, and integrated manner including the UDI system integration.

Why should you attend :

This webinar will provide great opportunities to get familiar with the FDA compliant medical device reporting requirements.

Areas Covered in the Session:

Statutes and Regulations

Definitions

Regulatory Requirements for MDR Procedures

New MDR Requirements

MDR Event Criteria

Reporting Foreign Events

How to Report A Medical Device Problem (MDR)

Reporting Requirements for the User Facilities, Manufacturers, and Importers

Relationships with Adverse Event Reporting Systems in EU and Health Canada

UDI System Integration

Common Mistakes

Good Practices: Suggestions and Recommendations

Conclusion

Who will benefit: (Titles)

CEOs

VPs

Clinical affairs (associates, specialists, managers, directors or VPs)

Regulatory affairs (associates, specialists, managers, directors or VPs)

Quality professionals (associates, specialists, managers, directors or VPs)

R&D (engineers, scientists, managers, directors or VPs)

Complaint and risk management personnel

Consultants

Anyone interested in the topics

Webinar Includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

60 Minutes Live Presentation

Certificate of Attendance