2020 - A Comprehensive View of FDA Regulations for Medical Devices

Learn the law, regulations, and policies that FDA applies for medical device
Understand the requirements to market a medical device in the US including device classification and conformity assessment paths
Understand the quality management systems that govern the design, manufacture, installation, and servicing of medical devices for the US market
Learn how UDI will affect medical devices and how to prepare for implementation
Understand the rules for Medical Device Reports (MDRs) and their relationship to complaints
Understand which devices must be tracked and how to set up and audit the system
Learn about correcting devices already shipped and when to report to FDA
Learn the role of FDA Inspections, the use of QSIT, and the possible outcomes of an inspection
Learn about inspectional observations and how to respond to a Form 483
Understand the issues manufacturers face by reviewing Warning Letters related to the topics covered