Medical device quality
Learn to plan and run an ISO 13485 internal audit across medical-device quality processes.
Advisera · English · 16 hours
Who this course is for
Quality professionals assigned to audit their own medical-device organisation.
What you’ll learn
- Medical-device QMS requirements
- Internal audit plans and interviews
- Traceability and audit evidence
Try this before you start
Pick a production lot and check whether purchasing, acceptance and release records tell a consistent story.
Exam and certificate
Advisera provides free online lessons. You can buy the proctored exam separately to earn the individual certificate. The provider shows the final price at checkout.
73 questions · 120 minutes · 50% in each competency and 70% in each competency unit