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GMPs for Medical Devices

GMPs for Medical Devices is a program that explains key GMP requirements for manufacturing medical device products. The program explains the term medical device and the medical device classification system. Additional information is provided on working in a regulated environment, a history of the medical device regulations and a detailed discussion of the GMP requirements.

Objectives:
At the end of this program, participants will be able to:

  • Define the term Medical Device
  • Recognize Medical Device Classifications
  • Describe a regulated environment
  • State who controls the medical device environment
  • Recall major events in the History of Medical Device Regulations
  • Describe how the Quality System Regulation works
  • Describe key GMPs and the Role of Every Employee
  • List important personal hygiene habits for working with medical devices
  • Describe key Benefits of Following GMPs
DVD Runtime: 15 Minutes
  • Extras
  • Leader's Guide
  • Discussion Guide and Answer Key
  • Assessment and Answer Key
This program is shipped directly from the US producer.