Medical device quality
Prepare to lead ISO 13485 audits that follow evidence through a medical-device quality management system.
Advisera · English · 30 hours
Who this course is for
Auditors and consultants preparing to lead medical-device QMS audits.
What you’ll learn
- Medical-device quality requirements
- Audit planning and team coordination
- Evidence and findings across processes
Try this before you start
Assign an audit trail from a design change through risk documentation, verification and controlled production records.
Workshop and exam
Start with Advisera’s free online lessons. For the individual credential, Advisera offers a paid workshop and exam package. Check the available dates and current price before booking.
93 questions · 150 minutes · 50% in each competency and 70% in each competency unit