GMP – Records For Medical Devices 1

GMP – Records for Medical Devices

Outlines the fundamental rules for completing records and discusses the requirements of the most frequently encountered records. Records include Device History Records, Equipment Records and Acceptance Activity Records.


– Define what records are
– Describe the general rules for completing records
– Explain what a quality system is and why medical device manufacturing companies use them
– List the information that must be entered on frequently used records
– List the types of records required in a medical device manufacturing company