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.

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

  1. Define the term Medical Device
  2. Recognize Medical Device Classifications
  3. Describe a regulated environment
  4. State who controls the medical device environment
  5. Recall major events in the History of Medical Device Regulations
  6. Describe how the Quality System Regulation works
  7. Describe key GMPs and the Role of Every Employee
  8. List important personal hygiene habits for working with medical devices
  9. Describe key Benefits of Following GMPs

Video Running Time: 15 Minutes

Program Materials Include:

  • Leader’s Guide
  • Discussion Guide and Answer Key
  • Assessment and Answer Key

Program available for distribution on company website. See License Type below for details.

Click on the link below to see a demo of this program.

Additional information


This product is available for immediate download. Once credit card payment is received, you will be sent an email containing a link to a compressed or zip file. Once you receive this file, unzip it and you will find two compressed files; one containing the Program Materials, the other the program video file. Unzip these two files and you will have your complete program.

License Type

Single Use (Play on 1 Computer or use DVD Player and Monitor) ($595), Network/Plant Wide (WMV Files for Use on Shared Drive) (+$595.00)


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