Improving Quality and Patient Safety with Recognition and Device Reporting

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
Conference Date
Wed, Jan 14, 2015
60 minutes
Product Description

Improving Medical Device Quality and Safety with Device Reporting and Recognition

Patient safety is the top priority for developing medical products including medical devices. The quality system regulations (QSR; aka cGMP) applicable for medical devices ensure that they are safe and effective as intended. 

This presentation by expert speaker Dr. David Lim, Ph.D., RAC, ASQ-CQAis intended to help industry professionals/firms get familiar with medical device quality and safety, which can be greatly improved with recognition and medical device reporting. The session is based on numerous exemplary and prior cases. The session is further intended to discuss how industry/firms can greatly improve patient safety under various environments with recognition and medical device reporting (for example – general, home, laboratory testing, pediatric and operating rooms). It will also help attendees understand medical device quality, reporting, safety and effectiveness so that the information shared can be used and put into actual practice under the particular environment.

This 60-minute session is intended to guide you through the details of how to improve quality and patient safety through recognition and medical device reporting.

Training Objective:

  • Applicable Laws and Regulations
  • Key Definitions
  • Medical Devices
  • Healthcare Trends
  • What to Consider under Various Environments
  • Medical Device Problems
  • Recognizing Problems
  • Patient Safety Issues
  • Importance of Reporting Medical Device Problems
  • How to Report Medical Device Problems
  • Increasing Awareness of Incidents
  • Encouraging Others to Report
  • Speaker’s Practical PASS-IT Guide

Who Should Attend

  • CEOs
  • VPs
  • Compliance Officers
  • Attorneys
  • Complainant Managers
  • Managers (RA, QA/QC, CA)
  • Consultants
  • Contractors and Subcontractors
  • Anyone interested in the topic



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About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor ( As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.

Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
More Events By The Speaker

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