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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 compliant with medical device standards. You will explore essential clauses, supplier management, validation processes, cleaning and sterilisation methods, and traceability for reusable tools. Develop expertise in conducting gap analyses, implementing in stages, performing internal audits, applying CAPA, monitoring KPIs, and conducting management reviews to achieve and maintain certification readiness effectively.

Elevify advantages

Develop skills

  • ISO 13485 fundamentals: understand the clauses, connections to FDA and EU regulations, and audit requirements quickly.
  • Supplier and production management: implement efficient, compliant procurement and supervision practices.
  • Conducting gap analysis: assess existing operations, identify risks, and develop corrective plans.
  • CAPA and internal auditing: examine problems, execute audits, and confirm outcomes.
  • Planning QMS implementation: structure phased rollouts, coordinate resources, and attain certification goals.

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 where I work.
SilviaNurse
Very great course. Lots of rich information.
WiltonCivil Firefighter

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