business standards course
Master key business standards for connected medical devices and navigate EU, French, and North African regulations. Build compliant quality systems, manage risk, data protection, and cybersecurity to strengthen your Business Law practice and client advice.

from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
This Business Standards Course gives you a practical overview of ISO 13485, ISO 14971, IEC 62304, GDPR, and key EU, French, and North African medical device regulations. Learn how to implement a compliant quality management system, manage suppliers, ensure cybersecurity and data protection, and prepare for audits, market access, post-market surveillance, and incident handling with clear, actionable steps.
Elevify advantages
Develop skills
- Apply EU MDR and French rules: fast-track safe market access for devices.
- Implement ISO 13485 QMS: build lean, audit-ready processes in weeks.
- Manage device cybersecurity: secure design, cloud controls, and GDPR basics.
- Run post-market surveillance: handle vigilance, PMCF, and recalls effectively.
- Perform compliance gap analyses: 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.What our students say
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