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ISO 13485 Course

ISO 13485 Course
4 to 360 hours flexible workload
valid certificate in your country

What will I learn?

The ISO 13485 Course provides a practical roadmap to build and improve a compliant quality management system for medical devices. Learn key clauses, supplier controls, validation, cleaning and sterilisation, and traceability for reusable instruments. Gain skills in gap analysis, phased implementation, internal audits, CAPA, KPIs, and management review so you can reach and sustain certification readiness with confidence.

Elevify advantages

Develop skills

  • ISO 13485 essentials: grasp clauses, FDA/EU links, and audit expectations fast.
  • Supplier and production control: apply lean, compliant purchasing and oversight.
  • Gap analysis execution: map current practices, expose risks, and plan fixes.
  • CAPA and internal audit: investigate issues, run audits, and verify results.
  • QMS roadmap planning: phase implementation, align resources, and hit certification.

Suggested summary

Before starting, you can change the chapters and the workload. Choose which chapter to start with. Add or remove chapters. Increase or decrease the course workload.
Workload: between 4 and 360 hours

What our students say

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EmersonPolice Investigator
The course was essential to meet the expectations of my boss and the company I work for.
SilviaNurse
Great course. Lots of valuable information.
WiltonCivil Firefighter

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