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ISO 13485 Lead Implementer Course

Medical device quality

Learn to organise an ISO 13485 implementation project across a medical-device quality management system.

Advisera · English · 30 hours

Gloved laboratory worker handling a sample with a pipette

Who this course is for

Medical-device quality leads and consultants responsible for setting up the QMS.

What you’ll learn

  • Planning and approving the project
  • Implementing medical-device QMS processes
  • Certification readiness and maintenance

Try this before you start

Map an implementation milestone to design control, supplier approval and training. Define the evidence showing each is ready.

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.

55 questions · 90 minutes · 50% in each competency and 70% in each competency unit