business standards course
Gain expertise in essential business standards for connected medical devices under EU French and North African rules. Develop compliant quality systems risk management data protection and cybersecurity to enhance business law practices and client guidance.

from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
Explore ISO 13485 ISO 14971 IEC 62304 GDPR and major EU French North African medical device regulations. Master building compliant quality systems supplier management cybersecurity data protection audit preparation market access post-market surveillance and incident response with practical steps.
Elevify advantages
Develop skills
- Apply EU MDR and French regulations for swift device market access.
- Implement ISO 13485 QMS with efficient audit-ready processes.
- Manage cybersecurity for devices including design and GDPR compliance.
- Conduct post-market surveillance for vigilance PMCF and recalls.
- Perform compliance gap analyses to identify fix risks and document.
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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