Introduction to Quality and Regulatory Affairs in MedTech

At the end of this short course, successful learners will be able to:

• Understand what quality means in the medical device industry
• Recognize how different roles contribute to quality and compliance
• Understand the reason for and types of audits and inspections
• Describe how medical devices are classified and regulated around the world
• Understand the role of regulatory affairs

This course is for individuals or organizations who want a short introduction to Quality and Regulatory Affairs in the Medical Device Industry.

Successful completion of the course examination will entitle each Learner to receive a digital Certificate of Completion.

In order to successfully complete this course, each Learner will need to:

• Complete all eLearning modules and obtain 70% or higher in the final assessment (MCQ-based)

There are recommended requirements for each Learner in wishing to complete any of our eLearning modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.