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business standards course

business standards course
4 to 360 hours flexible workload
valid certificate in your country

What will I learn?

This course provides a practical overview of ISO 13485, ISO 14971, IEC 62304, GDPR, and key EU, French, and North African medical device regulations. Learn to implement compliant quality management systems, manage suppliers, ensure cybersecurity and data protection, and prepare for audits, market access, post-market surveillance, and incident handling with actionable steps.

Elevify advantages

Develop skills

  • Apply EU MDR and French rules to fast-track safe market access for devices.
  • Implement ISO 13485 QMS to build lean, audit-ready processes in weeks.
  • Manage device cybersecurity with secure design, cloud controls, and GDPR basics.
  • Run post-market surveillance to handle vigilance, PMCF, and recalls effectively.
  • Perform compliance gap analyses to map standards, fix risks, and document proof.

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

I was just promoted to Intelligence Advisor for the Prison System, and the course from Elevify was crucial for me to be the chosen one.
EmersonPolice Investigator
The course was essential to meet the expectations of my boss and the company I work for.
SilviaNurse
Really great course. Lots of valuable information.
WiltonCivil Firefighter

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