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business standards course

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

What will I learn?

This course provides a practical overview of ISO 13485, ISO 14971, IEC 62304, GDPR, and vital EU, French, and North African medical device regulations. Master implementing compliant quality systems, supplier management, cybersecurity, data protection, audits, market access, post-market surveillance, and incident response with straightforward, actionable guidance.

Elevify advantages

Develop skills

  • Apply EU MDR and French regulations for swift, safe medical device market access.
  • Implement ISO 13485 QMS to establish efficient, audit-ready processes quickly.
  • Manage medical device cybersecurity with secure design, cloud controls, and GDPR compliance.
  • Conduct post-market surveillance effectively, including vigilance, PMCF, and recalls.
  • Perform compliance gap analyses to identify standards, mitigate risks, and document evidence.

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 chosen.
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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