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.
Who Should Attend
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). 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.