Description
The following FDA Report for Safer Medical Products for Healthcare Providers is designed to educate healthcare providers (HCP) on how to report medical device malfunctions, serious injuries, or deaths associated with medical devices to the FDA. Once completed, you will receive a certificate of completion.
The information contained in these trainings was derived from publications of OSHA, EEOC, DOL, OCR, FDA, CDC, NIAID, ATSDR, HHS or WHO (Government Sourced Material).
The Government Sourced Material used by AMC is available for no charge on their associated websites. The use of the Government Sourced Material by AMC does not imply endorsement or recommendation by OSHA, EEOC, DOL, OCR, FDA, CDC, NIAID, ATSDR, HHS or WHO or by the United States Government, of AMC, its enterprise, its facility, its services or its products.
Table of Contents
Summary of MDR Regulation
Overview of Medical Device Reporting
Mandatory MDR Requirements
Voluntary MDR Requirements
How to Report a Medical Device Problem
What you'll learn
Examine the Medical Device Reporting (MDR) regulation
Identify the voluntary and mandatory MDR requirements
Understand the process for reporting a medical device problem
American Medical Compliance
The following training modules are designed to educate Healthcare Providers (HCP) how to protect yourself/patients and mitigate community transmission of diseases like COVID-19 in the United States. Once completed, you will receive a certificate of completion to verify you have finished the training.
We are committed to Healthcare industry in offering compliance solutions specializing in all aspects of Infection Control, OSHA, HIPAA, and HR management systems. Healthcare compliance is Federally and State mandated and can be a time consuming, complicated burden on management and staff. Our compliance experts have developed state of the art training modules that are user-friendly and interactive.
Our state of the art online compliance center assures proper training and annual certifications for employees. Visit us on Amazon to purchase your State specific OSHA Medical/Dental manual. This includes office-specific policies and procedures in order to satisfy both Federal and State requirements. We will keep you HIPAA compliant and help you choose the HR solutions that make sense for your facility.
The information in these trainings were obtained in cooperation with the CDC, ATSDR, HHS and WHO and this does not imply endorsement or recommendation.
The information contained in these trainings was derived from publications of OSHA, EEOC, DOL, OCR, FDA, CDC, NIAID, ATSDR, HHS or WHO (Government Sourced Material). The Government Sourced Material used by AMC is available for no charge on their associated websites. The use of the Government Sourced Material by AMC does not imply endorsement or recommendation by OSHA, EEOC, DOL, OCR, FDA, CDC, NIAID, ATSDR, HHS or WHO or by the United States Government, of AMC, its enterprise, its facility, its services or its products.