Medical Device cGMPs Internationally
Good manufacturing practices are a set of principles and procedures that help ensure medical devices are manufactured with the required quality. In the United States they are referred to as “current” good manufacturing practices or cGMP’s, and are synonymous with the quality system regulation. Many countries require medical device manufacturers to demonstrate compliance with a quality management system prior to receiving permission to market and sell their devices. In this course, participants will gain an understanding of the medical device regulatory approval pathways and the role that GMP’s play in the medical device markets of China, Canada, Europe, Japan, Brazil and the United States.
This course is available online, and can be taken at your own pace.
Please note: You must complete the course within 3 months of registration.
- Lectures 0
- Hands-On Training 0
- Duration 3 hours
- Skill level All levels
- Wet Lab No
- Max Students 75
- Assessments Yes