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ISO 13485 Course

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

What will I learn?

The ISO 13485 Course provides a practical guide to establish and enhance a quality management system for medical devices that meets standards. You will learn about key clauses, managing suppliers, validation processes, cleaning and sterilisation, and tracking for reusable instruments. Develop abilities in gap analysis, step-by-step implementation, internal audits, corrective actions, performance indicators, and management reviews to achieve and maintain certification readiness confidently.

Elevify advantages

Develop skills

  • ISO 13485 basics: understand clauses, connections to FDA/EU, and what audits expect quickly.
  • Supplier and production management: use efficient, standard-compliant buying and supervision.
  • Conducting gap analysis: assess current methods, identify risks, and outline solutions.
  • CAPA and internal audits: examine problems, perform audits, and confirm outcomes.
  • Planning QMS roadmap: implement in stages, coordinate resources, and attain certification.

Suggested summary

Before starting, you can change the chapters and 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. A lot of valuable information.
WiltonCivil Firefighter

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