business standards course
Gain mastery of essential business standards for connected medical devices under EU French and North African regulations. Develop compliant quality systems manage risks data protection and cybersecurity to enhance your business law practice and client advisory services.

from 4 to 360h flexible workload
certificate valid in your country
What will I learn?
This course offers a practical guide to ISO 13485 ISO 14971 IEC 62304 GDPR and major EU French and North African medical device rules. You will learn to set up compliant quality management systems handle suppliers ensure cybersecurity and data protection and get ready for audits market entry post-market monitoring and incident management using straightforward practical steps.
Elevify advantages
Develop skills
- Apply EU MDR and French rules for quick safe market access for devices.
- Implement ISO 13485 QMS to build efficient audit-ready processes quickly.
- Manage device cybersecurity with secure design cloud controls and GDPR basics.
- Conduct post-market surveillance handling vigilance PMCF and recalls effectively.
- Perform compliance gap analyses mapping standards fixing risks and documenting proof.
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.What our students say
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