Webinar On Medical Device Reporting - How to establish and maintain adequate procedures - PowerPoint PPT Presentation

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Webinar On Medical Device Reporting - How to establish and maintain adequate procedures


Compliance Trainings would provide training on various concepts like Class I, II and III devices, 510(k), Premarket Approval (PMA), IVD’s (In Vitro Diagnostics) and Current Good Manufacturing Practices (cGMP). – PowerPoint PPT presentation

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Title: Webinar On Medical Device Reporting - How to establish and maintain adequate procedures

Contact Us 416-915-4458
We Empower, You Comply!
Medical Device Reporting - How to establish and
maintain adequate procedures
Product Id
Medical Devices
Scheduled On
Wednesday, May 14, 2014 at 1300 Hrs
60 Minutes
Dr. David Lim
To visit our website
Webinar Description

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 Regulations
  • Definitions
  • MDR Regulatory Requirements
  • MDR Standard Operating Procedures (SOPs)
    Required Elements
  • MDR Criteria
  • Determining and Reporting MDR Events
  • Reporting Requirements for the User Facilities,
    Manufacturers, and Importers
  • Integrating Unique Device Identification (UDI)
  • Enforcements  Case Studies
  • Common Mistakes and Consequences
  • Best Practices
  • Speakers PASS-IT Solutions

Who Will Benefit
  • Clinical Affairs
  • Regulatory Affairs
  • Quality
  • Research Development
  • Complaint and Risk Management
  • Consultants
  • Senior Management
  • Contractors/subcontractors
  • Other interested parties

Speaker Profile
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is
President and Principal of Regulatory Doctor
(www.RegulatoryDoctor.com). Dr. Lim frequently
presents global regulatory and quality compliance
topics in various forums and meetings. Recently,
Dr. Lim developed 510(k) templates ready for use
compliant with e-Copy and RTA policy. In
addition, Dr. Lim developed FDA inspection
checklists for drug and medical device
manufacturers based on his analysis of FDA
inspectional observations cited in 483s for the
past seven years. Dr. Lim provides his feedback
to regulatory agency (e.g., US FDA) through
public comments and also served as a panel member
during the FDAs transparency public meeting in
2009. Dr. Lim contributes to the Regulatory
Affairs Professional Society (RAPS) as an author.
Dr. Lim leads and directs all research projects
including pharmacovigilance, medical device
reporting, recalls and patient safety signals
being conducted at the Regulatory Doctor.

To register our webinar visit our website
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