Medical device quality
Understand how ISO 13485 applies quality management to medical-device design, purchasing, production and feedback.
Advisera · English · 8 hours · Beginner
Who this course is for
Medical-device quality, operations and regulatory staff learning how the QMS fits together.
What you’ll learn
- Medical-device QMS fundamentals
- Design and purchasing controls
- Measurement, feedback and improvement
Try this before you start
Follow a supplier-supplied component from approval to incoming checks and identify which records show it met requirements.
Exam and certificate
Advisera provides free online lessons. You can purchase the proctored exam separately if you want the individual certificate. The final price is shown at checkout.
29 questions · 45 minutes · Pass criteria: 50% in each competency and 70% in each competency unit
Advisera handles exam access and certificates. The course credential is issued to the learner.