ISO 13485 Course
This course equips participants with essential knowledge and skills to implement and maintain an ISO 13485-compliant quality management system for medical devices, covering standards, supplier management, validation, audits, and certification preparation.
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 that meets standards for medical devices. You will study main requirements, managing suppliers, validation processes, cleaning and sterilisation methods, and tracking for instruments that can be reused. Develop abilities in assessing gaps, step-by-step rollout, conducting internal checks, corrective actions, performance indicators, and leadership evaluations to achieve and maintain readiness for certification with assurance.
Elevify advantages
Develop skills
- ISO 13485 basics: understand the requirements, connections to FDA and EU rules, and what audits involve quickly.
- Managing suppliers and production: use efficient, rule-following methods for buying and supervising.
- Carrying out gap analysis: chart existing ways, identify dangers, and arrange solutions.
- CAPA and internal audits: examine problems, perform checks, and confirm outcomes.
- Planning the QMS path: stage the rollout, match resources, and attain 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.What our students say
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