business standards course
Master key business standards fi connected medical devices an' navigate EU, French, an' North African regulations. Build compliant quality systems, manage risk, data protection, an' cybersecurity fi strengthen yuh Business Law practice an' client advice wid clear steps.

from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
Dis Business Standards Course gi yuh a practical rundown pon ISO 13485, ISO 14971, IEC 62304, GDPR, an' main EU, French, an' North African medical device regs. Learn how fi implement a compliant quality management system, manage suppliers, secure cybersecurity an' data protection, an' prepare fi audits, market access, post-market surveillance, an' incident handling wid straightforward, actionable steps.
Elevify advantages
Develop skills
- Apply EU MDR an' French rules fi fast-track safe market access fi devices.
- Implement ISO 13485 QMS fi build lean, audit-ready processes in weeks.
- Manage device cybersecurity wid secure design, cloud controls, an' GDPR basics.
- Run post-market surveillance fi handle vigilance, PMCF, an' recalls effectively.
- Perform compliance gap analyses fi map standards, fix risks, an' 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 are saying
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