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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 Business Standards Course offers a practical overview of ISO 13485, ISO 14971, IEC 62304, GDPR, and vital EU, French, and North African medical device regulations. Discover how to establish a compliant quality management system, oversee suppliers, safeguard cybersecurity and data, and ready yourself for audits, market entry, post-market surveillance, and incident management using straightforward, actionable guidance.

Elevify advantages

Develop skills

  • Apply EU MDR and French regulations to expedite safe market access for medical devices.
  • Implement ISO 13485 QMS to establish efficient, audit-ready processes swiftly.
  • Manage medical device cybersecurity through secure design, cloud controls, and GDPR fundamentals.
  • Conduct post-market surveillance effectively, covering vigilance, PMCF, and recalls.
  • Perform compliance gap analyses by mapping standards, addressing risks, and documenting 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 Prison System Intelligence Advisor, 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
Great course. Lots of valuable information.
WiltonCivil Firefighter

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