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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?

Explore ISO 13485, ISO 14971, IEC 62304, GDPR, and vital EU, French, North African medical device rules. Master building compliant quality systems, supplier oversight, cybersecurity, data safeguards, audit preparation, market entry, post-market monitoring, and incident response through straightforward, practical 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 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 of 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 where I work.
SilviaNurse
Very great course. Lots of rich information.
WiltonCivil Firefighter

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