Medical Device Reporting Requirements for Manufacturers

Sale!

Medical device manufacturers are subject to medical device reporting for device-related adverse events and malfunctions including record-keeping requirements.

This webinar is intended to help you adequately establish and maintain medical device reporting procedures and practices and also to further help you avoid FDA 483s and warning letters.

In the United States, 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 what to consider and 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 implement best practices and stay compliant with statutory requirements and 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
  • Enforcements: Case Studies
  • Common Mistakes and Consequences
  • Best Practices
  • Speaker’s PASS-IT Solutions
Who Will Benefit:

  • Clinical Affairs
  • Regulatory Affairs
  • Quality
  • R&D
  • Complaint and Risk Management Personnel
  • Consultants
  • Senior Management
  • Contractors/subcontractors
  • Other interested parties

Dr. David Lim

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, 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 eight 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 FDA’s transparency public meeting in 2009.

Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.

membership
  Go PRIME   🛈 $ 240 SELECT
  Personal Plan 🛈 $ 3000 SELECT
  Business Plan 🛈 $ 9000 SELECT


  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance