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business standards course

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

What will I learn?

This course delivers a hands-on introduction to ISO 13485, ISO 14971, IEC 62304, GDPR, plus vital EU, French, and North African medical device rules. Master setting up compliant quality systems, supplier oversight, cybersecurity safeguards, data privacy, audit preparation, market entry strategies, post-market monitoring, and incident response with straightforward, practical guidance.

Elevify advantages

Develop skills

  • Apply EU MDR and French regulations for swift, safe medical device market entry.
  • Implement ISO 13485 QMS to establish efficient, audit-ready processes quickly.
  • Manage cybersecurity for medical devices with secure design, cloud controls, and GDPR compliance.
  • Conduct effective post-market surveillance including vigilance, PMCF, and product recalls.
  • Perform compliance gap analysis 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 the chosen one.
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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